HGI · Electrocautery, Gynecologic (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.4120 · Class 2
Overview
| Product Code | HGI |
|---|---|
| Device Name | Electrocautery, Gynecologic (And Accessories) |
| Regulation | 21 CFR 884.4120 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202915 | IRIS Thermocoagulator and Digital Colposcope | Liger Medical, LLC | Apr 23, 2021 | SESE |
| K152843 | Liger Medical HTU-110 | Liger Medical, LLC | Jun 24, 2016 | SESE |
| K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | Domain Surgical, Inc. | Jan 3, 2014 | SESE |
| K121881 | DOMAIN SURGICAL SYSTEM | Domain Surgical, Inc. | Oct 18, 2012 | SESE |
| K070877 | ENDOCERVICAL ELECTRODE # 2 | Modern Medical Equipment Mfg., Ltd. | Jul 27, 2007 | SESE |
| K061651 | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 | Apple Medical Corp. | Oct 20, 2006 | SESE |
| K022593 | THOMAS MEDICAL ELECTRODES | Thomas Medical, Inc. | Nov 1, 2002 | SESE |
| K003608 | SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | Feb 20, 2001 | SESE |
| K002042 | TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 | New England Medical Corp. | Feb 1, 2001 | SESE |
| K993527 | LOOP ELECTRODE, BALL ELECTRODE | Palm Medical USA, Inc. | Jul 6, 2000 | SESE |
| K993777 | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | R-Group Intl. | May 25, 2000 | SESE |
| K983840 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | Wallach Surgical Devices, Inc. | May 20, 1999 | SESE |
| K982739 | GYNEX ELECTRODES | Gynex Corp. | Mar 12, 1999 | SESE |
| K974138 | ROCKET ELECTRODE | A & A Medical, Inc. | Jan 30, 1998 | SESE |
| K971986 | VALLEY FORGE BIPOLAR LOOP | Valley Forge Scientific Corp. | Aug 26, 1997 | SESE |
| K965245 | TBD | Utah Medical Products, Inc. | Jul 3, 1997 | SESE |
| K963653 | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM | Wallach Surgical Devices, Inc. | Jun 11, 1997 | SESE |
| K963348 | WALLACH INTEGRATION UNIT | Wallach Surgical Devices, Inc. | Mar 19, 1997 | SESE |
| K963852 | KSEA THERMOCOAGULATOR (MODEL 265100 20) | KARL STORZ Endoscopy-America, Inc. | Dec 10, 1996 | SESE |
| K955756 | KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR | KARL STORZ Endoscopy-America, Inc. | Nov 26, 1996 | SESE |
Top Applicants
- Wallach Surgical Devices, Inc. — 5 clearances
- Utah Medical Products, Inc. — 4 clearances
- Valleylab, Inc. — 3 clearances
- Aaron Medical Industries — 2 clearances
- Apple Medical Corp. — 2 clearances
