Product code HFG
- Device name
- Coagulator, Laparoscopic, Unipolar (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4160
- 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 |
|---|---|---|---|
| K181124 | Acessa ProVu System | Acessa Health, Inc. | 2018-09-28 |
| K132744 | ACESSA GUIDANCE SYSTEM | Halt Medical, Inc. | 2014-05-27 |
| K132184 | ACESSA GUIDANCE HANDPIECE | Halt Medical, Inc. | 2014-04-28 |
| K121858 | THE ABLATION SYSTEM | Halt Medical, Inc. | 2012-11-05 |
| K101606 | MICROMED PD-8K INSULATION DEFECT DETECTOR | Mcgan Technology, LLC | 2010-10-01 |
| K991424 | INSULSCAN INSULATION TESTING SYSTEM | Medicor Corp. | 1999-07-22 |
| K961695 | ENDO-TECH LTD., TIPS | Ratio Design Lab | 1996-07-01 |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Davol, Inc. | 1994-03-25 |
| K915406 | DAVOL ELECTROSUGICAL PROBES | Davol, Inc. | 1992-02-28 |
| K904240 | SINGLE USE LAPARSCOPIC ELECTRODE | Aspen Labs | 1991-02-19 |
| K902555 | AMCATH COAGULATION PROBE | Intl. Medical, Inc. | 1990-06-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15420045515291 | Acessa ProVu System | Hologic, Inc. | 2024-09-13 |
| 15420045515277 | Acessa ProVu System | Hologic, Inc. | 2024-09-13 |
| 15420045515260 | Acessa ProVu System | Hologic, Inc. | 2024-09-13 |
| 15420045515314 | Acessa ProVu System | Hologic, Inc. | 2023-05-16 |
| 15420045515307 | Acessa ProVu System | Hologic, Inc. | 2023-05-16 |
| 15420045515253 | Acessa ProVu System | Hologic, Inc. | 2023-05-16 |
| 15420045515246 | Acessa ProVu System | Hologic, Inc. | 2023-05-16 |
| 15420045515284 | Acessa ProVu System | Hologic, Inc. | 2022-11-08 |
| 14042761086278 | Olympus | OLYMPUS Winter & Ibe GmbH | 2020-07-31 |
| 00854763006126 | Acessa Table Top Field Generator | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006249 | Acessa ProVu PFG Table Clamp | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006232 | Acessa ProVu System | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006195 | Acessa ProVu Planar Field Generator (PFG) | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006188 | Acessa ProVu Transducer with sensor | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006157 | Acessa ProVu Handpiece Cable | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006140 | Acessa ProVu Handpiece | ACESSA HEALTH INC. | 2018-10-11 |
| 00854763006119 | Acessa Pad Cable | ACESSA HEALTH INC. | 2018-10-11 |
| 30653405034838 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405034807 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405034784 | NA | Conmed Corporation | 2016-09-24 |
| 30653405034449 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009799 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009782 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009775 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009768 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009744 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009683 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009676 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009669 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405009652 | CONMED | Conmed Corporation | 2016-09-24 |