Atlas FDA

HGI

53 FDA 510(k) clearances · Product code

239 daysmedian time to decision
581 days90th percentile
53clearances measured

FDA profile

Official device name
Electrocautery, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4120
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 100 · 2022: 104 · 2023: 61 · 2024: 44 · 2025: 41 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IRIS Thermocoagulator and Digital Colposcope (K202915)Liger Medical, LLC2021-04-23
Liger Medical HTU-110 (K152843)Liger Medical, LLC2016-06-24
FMWAND FERROMAGNETIC SURGICAL SYSTEM (K130606)Domain Surgical, Inc.2014-01-03
DOMAIN SURGICAL SYSTEM (K121881)Domain Surgical, Inc.2012-10-18
ENDOCERVICAL ELECTRODE # 2 (K070877)Modern Medical Equipment Mfg., Ltd.2007-07-27
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (K061651)Apple Medical Corp.2006-10-20
THOMAS MEDICAL ELECTRODES (K022593)Thomas Medical, Inc.2002-11-01
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (K003608)Aesculap, Inc.2001-02-20
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (K002042)New England Medical Corp.2001-02-01
LOOP ELECTRODE, BALL ELECTRODE (K993527)Palm Medical USA, Inc.2000-07-06
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (K993777)R-Group Intl.2000-05-25
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) (K983840)Wallach Surgical Devices, Inc.1999-05-20
GYNEX ELECTRODES (K982739)Gynex Corp.1999-03-12
ROCKET ELECTRODE (K974138)A & A Medical, Inc.1998-01-30
VALLEY FORGE BIPOLAR LOOP (K971986)Valley Forge Scientific Corp.1997-08-26
TBD (K965245)Utah Medical Products, Inc.1997-07-03
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM (K963653)Wallach Surgical Devices, Inc.1997-06-11
WALLACH INTEGRATION UNIT (K963348)Wallach Surgical Devices, Inc.1997-03-19
KSEA THERMOCOAGULATOR (MODEL 265100 20) (K963852)KARL STORZ Endoscopy-America, Inc.1996-12-10
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR (K955756)KARL STORZ Endoscopy-America, Inc.1996-11-26
LWEET CONE BIOPSY INSTRUMENT (K961460)Apple Medical Corp.1996-11-19
LOOP/SQUARE ELECTRODE (K952030)E & M Engineering, Inc.1996-07-31
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 (K955093)Utah Medical Products, Inc.1996-04-29
LEEP SYSTEM 1000 (K952483)CooperSurgical, Inc.1995-10-06
SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE (K944450)Unimed Surgical Products, Inc.1995-07-25
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM (K921791)Wallach Surgical Devices, Inc.1995-05-04
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP) (K942986)Aaron Medical Industries1995-03-21
ELECTROSURGICAL LOOP ELECTRODE (K940191)National Wire & Stamping, Inc.1994-12-30
FINESSE IEC/601 (K941251)Utah Medical Products, Inc.1994-12-12
SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE (K925333)Aspen Labs1994-09-27
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES (K925560)Zinnanti Surgical Instruments, Inc.1994-08-30
WALLACH LEEP PROCEDURE KIT (K935634)Wallach Surgical Devices, Inc.1994-07-20
ELECTROSURGICAL ELECTRODE (K925478)Megadyne Medical Products, Inc.1994-06-27
MODEL 26-0375, ELECTROSURGICAL GENERATOR (K931541)Cameron-Miller, Inc.1994-06-01
MODEL 80-1983, ELECTROSURGICAL GENERATOR (K931437)Cameron-Miller, Inc.1994-05-27
LEEP AND LLETZ ELECTRODES (K930132)Nordex Medical Corp.1994-05-04
SEDLACEK HANDLE (K926179)Simpson/Basye, Inc.1994-03-25
CRYOMEDICS LLETZ LOOPS (K923570)Cabot Medical Corp.1994-02-28
CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE (K923628)Bruce Mclucas1994-02-22
16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP) (K931338)Aaron Medical Industries1994-02-16
SUOP ELECTRODES FOR EXCISIONAL PROCEDURES (K921386)Silver Creek Surgical1993-10-08
SURGISTAT (K922206)Valleylab, Inc.1993-09-07
FORCE 2 (K921884)Valleylab, Inc.1992-12-15
FORCE 1C (K921222)Valleylab, Inc.1992-09-23
ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 (K914367)Gyne-Tech Instrument Corp.1992-04-28
SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION (K914329)Ellman Intl. Mfg., Inc.1992-04-02
SINGLE USE LEE ELECTRODE (K912046)Aspen Labs1992-03-05
SINGLE USE LEE ELECTRODE (K913213)Aspen Laboratories, Inc.1992-02-13
UTAH ESSU (K905263)Utah Medical Products, Inc.1991-09-18
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR (K905747)Coopervision Surgical1991-09-17
ENDOCOAGULATOR 2001 KLI (K895402)Cabot Medical Corp.1990-04-26
MONITOR, FETAL HEART, MODEL 1980 (K770292)Berkeley Bio-Engineering1977-03-09
ABDOMINAL ECG PROCESSOR FOR FETAL MONI. (K770295)Brattle Instrument Corp.1977-03-09

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Every clearance here is in the API, with alerts when new ones post.