FDA Product Code
FDA Product Code HGI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4120
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202915 | IRIS Thermocoagulator and Digital Colposcope | Liger Medical, LLC | 2021-04-23 | Traditional | PDF ↗ |
| K152843 | Liger Medical HTU-110 | Liger Medical, LLC | 2016-06-24 | Traditional | PDF ↗ |
| K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | Domain Surgical, Inc. | 2014-01-03 | Traditional | PDF ↗ |
| K121881 | DOMAIN SURGICAL SYSTEM | Domain Surgical, Inc. | 2012-10-18 | Traditional | PDF ↗ |
| K070877 | ENDOCERVICAL ELECTRODE # 2 | Modern Medical Equipment Mfg., Ltd. | 2007-07-27 | Traditional | PDF ↗ |
| K061651 | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 | Apple Medical Corp. | 2006-10-20 | Traditional | PDF ↗ |
| K022593 | THOMAS MEDICAL ELECTRODES | Thomas Medical, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K003608 | SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | 2001-02-20 | Traditional | PDF ↗ |
| K002042 | TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 | New England Medical Corp. | 2001-02-01 | Traditional | PDF ↗ |
| K993527 | LOOP ELECTRODE, BALL ELECTRODE | Palm Medical USA, Inc. | 2000-07-06 | Traditional | PDF ↗ |
| K993777 | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | R-Group Intl. | 2000-05-25 | Traditional | PDF ↗ |
| K983840 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | Wallach Surgical Devices, Inc. | 1999-05-20 | Traditional | PDF ↗ |
| K982739 | GYNEX ELECTRODES | Gynex Corp. | 1999-03-12 | Traditional | PDF ↗ |
| K974138 | ROCKET ELECTRODE | A & A Medical, Inc. | 1998-01-30 | Traditional | PDF ↗ |
| K971986 | VALLEY FORGE BIPOLAR LOOP | Valley Forge Scientific Corp. | 1997-08-26 | Traditional | PDF ↗ |
| K965245 | TBD | Utah Medical Products, Inc. | 1997-07-03 | Traditional | PDF ↗ |
| K963653 | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM | Wallach Surgical Devices, Inc. | 1997-06-11 | Traditional | PDF ↗ |
| K963348 | WALLACH INTEGRATION UNIT | Wallach Surgical Devices, Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K963852 | KSEA THERMOCOAGULATOR (MODEL 265100 20) | KARL STORZ Endoscopy-America, Inc. | 1996-12-10 | Traditional | PDF ↗ |
| K955756 | KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR | KARL STORZ Endoscopy-America, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K961460 | LWEET CONE BIOPSY INSTRUMENT | Apple Medical Corp. | 1996-11-19 | Traditional | PDF ↗ |
| K952030 | LOOP/SQUARE ELECTRODE | E & M Engineering, Inc. | 1996-07-31 | Traditional | PDF ↗ |
| K955093 | ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 | Utah Medical Products, Inc. | 1996-04-29 | Traditional | PDF ↗ |
| K952483 | LEEP SYSTEM 1000 | CooperSurgical, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K944450 | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE | Unimed Surgical Products, Inc. | 1995-07-25 | Traditional | PDF ↗ |
| K921791 | WALLACH LEAP 100 ELECTRO SURGERY SYSTEM | Wallach Surgical Devices, Inc. | 1995-05-04 | Traditional | PDF ↗ |
| K942986 | ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP) | Aaron Medical Industries | 1995-03-21 | Traditional | PDF ↗ |
| K940191 | ELECTROSURGICAL LOOP ELECTRODE | National Wire & Stamping, Inc. | 1994-12-30 | Traditional | PDF ↗ |
| K941251 | FINESSE IEC/601 | Utah Medical Products, Inc. | 1994-12-12 | Traditional | PDF ↗ |
| K925333 | SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE | Aspen Labs | 1994-09-27 | Traditional | PDF ↗ |
| K925560 | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES | Zinnanti Surgical Instruments, Inc. | 1994-08-30 | Traditional | PDF ↗ |
| K935634 | WALLACH LEEP PROCEDURE KIT | Wallach Surgical Devices, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K925478 | ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 1994-06-27 | Traditional | PDF ↗ |
| K931541 | MODEL 26-0375, ELECTROSURGICAL GENERATOR | Cameron-Miller, Inc. | 1994-06-01 | Traditional | PDF ↗ |
| K931437 | MODEL 80-1983, ELECTROSURGICAL GENERATOR | Cameron-Miller, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K930132 | LEEP AND LLETZ ELECTRODES | Nordex Medical Corp. | 1994-05-04 | Traditional | PDF ↗ |
| K926179 | SEDLACEK HANDLE | Simpson/Basye, Inc. | 1994-03-25 | Traditional | PDF ↗ |
| K923570 | CRYOMEDICS LLETZ LOOPS | Cabot Medical Corp. | 1994-02-28 | Traditional | PDF ↗ |
| K923628 | CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE | Bruce Mclucas | 1994-02-22 | Traditional | PDF ↗ |
| K931338 | 16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP) | Aaron Medical Industries | 1994-02-16 | Traditional | PDF ↗ |
| K921386 | SUOP ELECTRODES FOR EXCISIONAL PROCEDURES | Silver Creek Surgical | 1993-10-08 | Traditional | PDF ↗ |
| K922206 | SURGISTAT | Valleylab, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K921884 | FORCE 2 | Valleylab, Inc. | 1992-12-15 | Traditional | PDF ↗ |
| K921222 | FORCE 1C | Valleylab, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K914367 | ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 | Gyne-Tech Instrument Corp. | 1992-04-28 | Traditional | PDF ↗ |
| K914329 | SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION | Ellman Intl. Mfg., Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K912046 | SINGLE USE LEE ELECTRODE | Aspen Labs | 1992-03-05 | Traditional | PDF ↗ |
| K913213 | SINGLE USE LEE ELECTRODE | Aspen Laboratories, Inc. | 1992-02-13 | Traditional | PDF ↗ |
| K905263 | UTAH ESSU | Utah Medical Products, Inc. | 1991-09-18 | Traditional | PDF ↗ |
| K905747 | LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR | Coopervision Surgical | 1991-09-17 | Traditional | PDF ↗ |
| K895402 | ENDOCOAGULATOR 2001 KLI | Cabot Medical Corp. | 1990-04-26 | Traditional | PDF ↗ |
| K770295 | ABDOMINAL ECG PROCESSOR FOR FETAL MONI. | Brattle Instrument Corp. | 1977-03-09 | Traditional | PDF ↗ |
| K770292 | MONITOR, FETAL HEART, MODEL 1980 | Berkeley Bio-Engineering | 1977-03-09 | Traditional | PDF ↗ |
Product code HGI · Class II · Obstetrics/Gynecology. Data: openFDA.