FDA product code HFG: Coagulator, Laparoscopic, Unipolar (And Accessories)
HFG is the FDA product code for coagulator, laparoscopic, unipolar (and accessories). It is a Class II device, regulated under 21 CFR 884.4160 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 11 510(k) submissions under HFG, from 8 different applicants. The average 510(k) review took 190 days (median 132).
Classification
| Field | Value |
|---|---|
| Device name | Coagulator, Laparoscopic, Unipolar (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.4160 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HFG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 151 |
Compare with all 510(k) review times · Search every HFG clearance
Top HFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Halt Medical, Inc. | 3 | 2014-05-27 |
| Davol, Inc. | 2 | 1994-03-25 |
| Acessa Health, Inc. | 1 | 2018-09-28 |
| Mcgan Technology, LLC | 1 | 2010-10-01 |
| Medicor Corp. | 1 | 1999-07-22 |
3 more applicants have HFG clearances. See the full list in Caduvo.
Most recent HFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181124 | Acessa Health, Inc. | Acessa ProVu System | 2018-09-28 | 151 |
| K132744 | Halt Medical, Inc. | ACESSA GUIDANCE SYSTEM | 2014-05-27 | 266 |
| K132184 | Halt Medical, Inc. | ACESSA GUIDANCE HANDPIECE | 2014-04-28 | 287 |
| K121858 | Halt Medical, Inc. | THE ABLATION SYSTEM | 2012-11-05 | 132 |
| K101606 | Mcgan Technology, LLC | MICROMED PD-8K INSULATION DEFECT DETECTOR | 2010-10-01 | 115 |
Recalls for HFG devices
openFDA lists no recalls for product code HFG.
Frequently asked questions
What is FDA product code HFG?
HFG is the FDA product code for coagulator, laparoscopic, unipolar (and accessories). It is a Class II device, regulated under 21 CFR 884.4160 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFG?
Class II, regulation 21 CFR 884.4160. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFG?
Across 11 cleared submissions the average was 190 days from receipt to decision (median 132).
Which companies have the most HFG clearances?
Halt Medical, Inc. (3); Davol, Inc. (2); Acessa Health, Inc. (1); Mcgan Technology, LLC (1); Medicor Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HFG
- Run a recall and safety report across every HFG manufacturer
- Watch product code HFG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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