FDA product code HAM: Apparatus, Electrosurgical
HAM is the FDA product code for apparatus, electrosurgical. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 31 510(k) submissions under HAM, from 22 different applicants. The average 510(k) review took 63 days (median 25). FDA has posted 3 recalls for HAM devices.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Electrosurgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HAM clearance
Top HAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olsen Electrosurgical, Inc. | 5 | 1988-10-24 |
| Beacon Laboratories, Inc. | 4 | 1992-02-03 |
| Edward Weck, Inc. | 2 | 1983-11-29 |
| Medical Products Development, Inc. | 2 | 1981-02-12 |
| Itl Corporation Pty, Ltd. | 1 | 2016-06-23 |
17 more applicants have HAM clearances. See the full list in Caduvo.
Most recent HAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153472 | Itl Corporation Pty, Ltd. | Quiver Laparoscopic Extendable | 2016-06-23 | 204 |
| K000079 | Nikomed U.S.A., Inc. | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | 2000-02-04 | 24 |
| K993306 | Paladin Medical, Inc. | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) | 1999-11-03 | 30 |
| K945861 | Bergen Mfg. | BERGEN 710 ESU | 1995-03-01 | 90 |
| K913300 | Cook Ob/Gyn | LAPAROSTAT(TM) | 1992-04-02 | 252 |
Recalls for HAM devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-12-27.
Frequently asked questions
What is FDA product code HAM?
HAM is the FDA product code for apparatus, electrosurgical. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is HAM?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code HAM?
Across 31 cleared submissions the average was 63 days from receipt to decision (median 25).
Which companies have the most HAM clearances?
Olsen Electrosurgical, Inc. (5); Beacon Laboratories, Inc. (4); Edward Weck, Inc. (2); Medical Products Development, Inc. (2); Itl Corporation Pty, Ltd. (1).
Have HAM devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2012-12-27.
Next steps
- Run an FDA pathway report with predicate devices for product code HAM
- Run a recall and safety report across every HAM manufacturer
- Watch product code HAM 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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