FDA 510(k) Applications for Medical Device Product Code "HGI"
(Electrocautery, Gynecologic (And Accessories))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K974138 | A & A MEDICAL, INC. | ROCKET ELECTRODE | 01/30/1998 |
| K003608 | AESCULAP, INC. | SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY | 02/20/2001 |
| K061651 | APPLE MEDICAL CORP. | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 | 10/20/2006 |
| K961460 | APPLE MEDICAL CORP. | LWEET CONE BIOPSY INSTRUMENT | 11/19/1996 |
| K121881 | DOMAIN SURGICAL, INC. | DOMAIN SURGICAL SYSTEM | 10/18/2012 |
| K130606 | DOMAIN SURGICAL, INC. | FMWAND FERROMAGNETIC SURGICAL SYSTEM | 01/03/2014 |
| K952030 | E & M ENGINEERING, INC. | LOOP/SQUARE ELECTRODE | 07/31/1996 |
| K982739 | GYNEX CORP. | GYNEX ELECTRODES | 03/12/1999 |
| K955756 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR | 11/26/1996 |
| K963852 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA THERMOCOAGULATOR (MODEL 265100 20) | 12/10/1996 |
| K202915 | Liger Medical, LLC | IRIS Thermocoagulator and Digital Colposcope | 04/23/2021 |
| K152843 | LIGER MEDICAL, LLC | Liger Medical HTU-110 | 06/24/2016 |
| K070877 | MODERN MEDICAL EQUIPMENT MFG., LTD. | ENDOCERVICAL ELECTRODE # 2 | 07/27/2007 |
| K002042 | NEW ENGLAND MEDICAL CORP. | TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 | 02/01/2001 |
| K993527 | PALM MEDICAL USA, INC. | LOOP ELECTRODE, BALL ELECTRODE | 07/06/2000 |
| K993777 | R-GROUP INTL. | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | 05/25/2000 |
| K022593 | THOMAS MEDICAL, INC. | THOMAS MEDICAL ELECTRODES | 11/01/2002 |
| K955093 | UTAH MEDICAL PRODUCTS, INC. | ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 | 04/29/1996 |
| K965245 | UTAH MEDICAL PRODUCTS, INC. | TBD | 07/03/1997 |
| K971986 | VALLEY FORGE SCIENTIFIC CORP. | VALLEY FORGE BIPOLAR LOOP | 08/26/1997 |
| K963348 | WALLACH SURGICAL DEVICES, INC. | WALLACH INTEGRATION UNIT | 03/19/1997 |
| K963653 | WALLACH SURGICAL DEVICES, INC. | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM | 06/11/1997 |
| K983840 | WALLACH SURGICAL DEVICES, INC. | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | 05/20/1999 |
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