HGI — Electrocautery, Gynecologic (And Accessories) Class II
FDA Device Classification
Classification Details
- Product Code
- HGI
- Device Class
- Class II
- Regulation Number
- 884.4120
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K202915 | liger medical | IRIS Thermocoagulator and Digital Colposcope | April 23, 2021 |
| K152843 | liger medical | Liger Medical HTU-110 | June 24, 2016 |
| K130606 | domain surgical | FMWAND FERROMAGNETIC SURGICAL SYSTEM | January 3, 2014 |
| K121881 | domain surgical | DOMAIN SURGICAL SYSTEM | October 18, 2012 |
| K070877 | modern medical equipment mfg | ENDOCERVICAL ELECTRODE # 2 | July 27, 2007 |
| K061651 | apple medical | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 | October 20, 2006 |
| K022593 | thomas medical | THOMAS MEDICAL ELECTRODES | November 1, 2002 |
| K003608 | aesculap | SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY | February 20, 2001 |
| K002042 | new england medical | TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 | February 1, 2001 |
| K993527 | palm medical usa | LOOP ELECTRODE, BALL ELECTRODE | July 6, 2000 |
| K993777 | r-group intl | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | May 25, 2000 |
| K983840 | wallach surgical devices | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | May 20, 1999 |
| K982739 | gynex | GYNEX ELECTRODES | March 12, 1999 |
| K974138 | a and a medical | ROCKET ELECTRODE | January 30, 1998 |
| K971986 | valley forge scientific | VALLEY FORGE BIPOLAR LOOP | August 26, 1997 |
| K965245 | utah medical products | TBD | July 3, 1997 |
| K963653 | wallach surgical devices | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM | June 11, 1997 |
| K963348 | wallach surgical devices | WALLACH INTEGRATION UNIT | March 19, 1997 |
| K963852 | karl storz endoscopy-america | KSEA THERMOCOAGULATOR (MODEL 265100 20) | December 10, 1996 |
| K955756 | karl storz endoscopy-america | KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR | November 26, 1996 |