Product code HGI— Obstetrics/Gynecology
SINGLE USE LEE ELECTRODE
- Classification name
- Electrocautery, Gynecologic (And Accessories)
- Device class
- Class 2
- Regulation
- 21 CFR 884.4120
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 53
- First cleared
- Most recent
Market context for product code HGI
FDA has cleared devices under product code HGI between 1977 and 2021, filed by 36 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2016
- 2014
- 2012
- 2007
- 2006
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
Top applicants under product code HGI
Adverse events under product code HGI
product code HGI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HGI
- K202915 — IRIS Thermocoagulator and Digital Colposcope
- K152843 — Liger Medical HTU-110
- K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM
- K121881 — DOMAIN SURGICAL SYSTEM
- K070877 — ENDOCERVICAL ELECTRODE # 2
- K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
- K022593 — THOMAS MEDICAL ELECTRODES
- K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
- K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
- K993527 — LOOP ELECTRODE, BALL ELECTRODE
- K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
- K983840 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
- K982739 — GYNEX ELECTRODES
- K974138 — ROCKET ELECTRODE
- K971986 — VALLEY FORGE BIPOLAR LOOP
- K965245 — TBD
- K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
- K963348 — WALLACH INTEGRATION UNIT
- K963852 — KSEA THERMOCOAGULATOR (MODEL 265100 20)
- K955756 — KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
- K961460 — LWEET CONE BIOPSY INSTRUMENT
- K952030 — LOOP/SQUARE ELECTRODE
- K955093 — ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
- K952483 — LEEP SYSTEM 1000
- K944450 — SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
- K921791 — WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
- K942986 — ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
- K940191 — ELECTROSURGICAL LOOP ELECTRODE
- K941251 — FINESSE IEC/601
- K925333 — SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
- K925560 — ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
- K935634 — WALLACH LEEP PROCEDURE KIT
- K925478 — ELECTROSURGICAL ELECTRODE
- K931541 — MODEL 26-0375, ELECTROSURGICAL GENERATOR
- K931437 — MODEL 80-1983, ELECTROSURGICAL GENERATOR
- K930132 — LEEP AND LLETZ ELECTRODES
- K926179 — SEDLACEK HANDLE
- K923570 — CRYOMEDICS LLETZ LOOPS
- K923628 — CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE
- K931338 — 16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
- K921386 — SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
- K922206 — SURGISTAT
- K921884 — FORCE 2
- K921222 — FORCE 1C
- K914367 — ELECTROSURGICAL GENERATOR MODEL ESU100/250/550
- K914329 — SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
- K912046 — SINGLE USE LEE ELECTRODE
- K913213 — SINGLE USE LEE ELECTRODE
- K905263 — UTAH ESSU
- K905747 — LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR
- K895402 — ENDOCOAGULATOR 2001 KLI
- K770292 — MONITOR, FETAL HEART, MODEL 1980
- K770295 — ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
Data sourced from openFDA. This site is unofficial and independent of the FDA.