HFG
11 FDA 510(k) clearances · Product code
132 daysmedian time to decision
287 days90th percentile
11clearances measured
FDA profile
- Official device name
- Coagulator, Laparoscopic, Unipolar (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 20 · 2022: 20 · 2023: 36 · 2024: 21 · 2025: 32 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Acessa ProVu System (K181124) | Acessa Health, Inc. | 2018-09-28 |
| ACESSA GUIDANCE SYSTEM (K132744) | Halt Medical, Inc. | 2014-05-27 |
| ACESSA GUIDANCE HANDPIECE (K132184) | Halt Medical, Inc. | 2014-04-28 |
| THE ABLATION SYSTEM (K121858) | Halt Medical, Inc. | 2012-11-05 |
| MICROMED PD-8K INSULATION DEFECT DETECTOR (K101606) | Mcgan Technology, LLC | 2010-10-01 |
| INSULSCAN INSULATION TESTING SYSTEM (K991424) | Medicor Corp. | 1999-07-22 |
| ENDO-TECH LTD., TIPS (K961695) | Ratio Design Lab | 1996-07-01 |
| DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP (K921405) | Davol, Inc. | 1994-03-25 |
| DAVOL ELECTROSUGICAL PROBES (K915406) | Davol, Inc. | 1992-02-28 |
| SINGLE USE LAPARSCOPIC ELECTRODE (K904240) | Aspen Labs | 1991-02-19 |
| AMCATH COAGULATION PROBE (K902555) | Intl. Medical, Inc. | 1990-06-20 |
Track HFG automatically
Every clearance here is in the API, with alerts when new ones post.