Description
FDA has developed thisguidance documentto assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery. These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices may also be called radiofrequency (RF) devices or high-frequency (HF) devices.
Scope & Applicability
Product Classes
10Devices intended to cut/remove tissue and control bleeding using high-frequency electrical current.
device intended to seal isolated blood and lymphatic vessels
technique where current flows from active electrode through patient to neutral electrode
type of monopolar electrosurgical device
includes the ESU, active accessories, neutral electrodes, and miscellaneous accessories
device that passes high-frequency electrical current through soft tissues
use of electric current to heat an instrument applied to tissue
electrosurgical device in which the current flows between two active electrodes
electrosurgical device that combines argon gas with RF current
General surgery devices requiring premarket notification; devices for general surgery and aesthetic use
Regulatory Context
Attributes
7Risk-based approach to determine information amount for premarket submission
frequencies ranging from 100 kHz to 5 MHz
Performance characteristic of neutral electrodes
required level for sterilized devices
Level of documentation required based on risk; higher documentation threshold for software functions; Risk-based documentation category requiring more detail; Outcome for software functions where failure presents a probable risk of death or serious injury; Outcome for devices where software failure presents a probable risk of death or serious injury.
Previous risk classification for ultrasonic diathermy devices under superseded guidance.; FDA's classification of software for ultrasonic diathermy devices
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Identified Hazards
Hazards
5Risk of febrile reaction
risk associated with argon enhanced devices
carcinogenic and infectious potential of byproducts
Risk of active coupling resistance between device and cannula; may cause injuries due to unintended activation
risk of febrile reaction addressed by pyrogenicity testing
Related CFR Sections (11)
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR878.4400§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.Read full regulation →
- 21CFR872.4920§ 872.4920 Dental electrosurgical unit and accessories.
(a) Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavityRead full regulation →
- 21CFR876.4300§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a) Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical aRead full regulation →
- 21CFR882.4400§ 882.4400 Radiofrequency lesion generator.
(a) Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.Read full regulation →
- 21CFR882.4725§ 882.4725 Radiofrequency lesion probe.
(a) Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.Read full regulation →
- 21CFR884.4150§ 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a) Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical coRead full regulation →
- 21CFR884.4160§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a) Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative prRead full regulation →
- 21CFR886.4100§ 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a) Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.Read full regulation →
- 21CFR886.4115§ 886.4115 Thermal cautery unit.
(a) Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers (Status: Draft)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases (Status: Final)