Product code HGI
- Device name
- Electrocautery, Gynecologic (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4120
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202915 | IRIS Thermocoagulator and Digital Colposcope | Liger Medical, LLC | 2021-04-23 |
| K152843 | Liger Medical HTU-110 | Liger Medical, LLC | 2016-06-24 |
| K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | Domain Surgical, Inc. | 2014-01-03 |
| K121881 | DOMAIN SURGICAL SYSTEM | Domain Surgical, Inc. | 2012-10-18 |
| K070877 | ENDOCERVICAL ELECTRODE # 2 | Modern Medical Equipment Mfg., Ltd. | 2007-07-27 |
| K061651 | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 | Apple Medical Corp. | 2006-10-20 |
| K022593 | THOMAS MEDICAL ELECTRODES | Thomas Medical, Inc. | 2002-11-01 |
| K003608 | SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | 2001-02-20 |
| K002042 | TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 | New England Medical Corp. | 2001-02-01 |
| K993527 | LOOP ELECTRODE, BALL ELECTRODE | Palm Medical USA, Inc. | 2000-07-06 |
| K993777 | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | R-Group Intl. | 2000-05-25 |
| K983840 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | Wallach Surgical Devices, Inc. | 1999-05-20 |
| K982739 | GYNEX ELECTRODES | Gynex Corp. | 1999-03-12 |
| K974138 | ROCKET ELECTRODE | A & A Medical, Inc. | 1998-01-30 |
| K971986 | VALLEY FORGE BIPOLAR LOOP | Valley Forge Scientific Corp. | 1997-08-26 |
| K965245 | TBD | Utah Medical Products, Inc. | 1997-07-03 |
| K963653 | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM | Wallach Surgical Devices, Inc. | 1997-06-11 |
| K963348 | WALLACH INTEGRATION UNIT | Wallach Surgical Devices, Inc. | 1997-03-19 |
| K963852 | KSEA THERMOCOAGULATOR (MODEL 265100 20) | KARL STORZ Endoscopy-America, Inc. | 1996-12-10 |
| K955756 | KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR | KARL STORZ Endoscopy-America, Inc. | 1996-11-26 |
| K961460 | LWEET CONE BIOPSY INSTRUMENT | Apple Medical Corp. | 1996-11-19 |
| K952030 | LOOP/SQUARE ELECTRODE | E & M Engineering, Inc. | 1996-07-31 |
| K955093 | ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 | Utah Medical Products, Inc. | 1996-04-29 |
| K952483 | LEEP SYSTEM 1000 | CooperSurgical, Inc. | 1995-10-06 |
| K944450 | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE | Unimed Surgical Products, Inc. | 1995-07-25 |
| K921791 | WALLACH LEAP 100 ELECTRO SURGERY SYSTEM | Wallach Surgical Devices, Inc. | 1995-05-04 |
| K942986 | ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP) | Aaron Medical Industries | 1995-03-21 |
| K940191 | ELECTROSURGICAL LOOP ELECTRODE | National Wire & Stamping, Inc. | 1994-12-30 |
| K941251 | FINESSE IEC/601 | Utah Medical Products, Inc. | 1994-12-12 |
| K925333 | SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE | Aspen Labs | 1994-09-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| GYNX1410201 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX1412181 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX1412201 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX1710131 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX1710181 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| GYNX1410151 | Gynex | GYNEX CORPORATION | 2023-06-29 |
| H671DLPM110 | UtahLoop | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPU110 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPN050 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPN110 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPS050 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPS110 | UtahLoop | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPSQ10 | UtahLoop | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPSQ20 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPSQ30 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPT050 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPT110 | LETZ | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPU050 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPM050 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPL110 | UtahLoop | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPE110 | UtahLoop | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPB110 | UtahLoop | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DLPB050 | N/A | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DCE1250 | C-LETZ | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DCE1200 | C-LETZ | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DCE1150 | C-LETZ | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DCE1100 | C-LETZ | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DBL5110 | UtahBall | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DBL5050 | UtahBall | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671DBL3110 | UtahBall | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |