HAM · Apparatus, Electrosurgical
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | HAM |
|---|---|
| Device Name | Apparatus, Electrosurgical |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153472 | Quiver Laparoscopic Extendable | Itl Corporation Pty, Ltd. | Jun 23, 2016 | SESE |
| K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | Nikomed U.S.A., Inc. | Feb 4, 2000 | SESE |
| K993306 | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) | Paladin Medical, Inc. | Nov 3, 1999 | SESE |
| K945861 | BERGEN 710 ESU | Bergen Mfg. | Mar 1, 1995 | SESE |
| K913300 | LAPAROSTAT(TM) | Cook Ob/Gyn | Apr 2, 1992 | SESE |
| K920100 | GSU HANDPIECE ADAPTER | Beacon Laboratories, Inc. | Feb 3, 1992 | SESE |
| K911353 | EMC MODEL NO. STATOME 900 | Emc Industries | Jun 24, 1991 | SESE |
| K901248 | ABC HANDPIECE ADAPTER | Beacon Laboratories, Inc. | Apr 3, 1990 | SESE |
| K881334 | LIGHT COAGULATOR LC 250 | Nk-Optik GmbH | Nov 16, 1989 | SESE |
| K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | New England Surgical Instrument Corp. | Sep 15, 1989 | SESE |
| K894762 | B100 DISPOSABLE HANDPIECE | Beacon Laboratories, Inc. | Sep 15, 1989 | SESE |
| K894663 | BEAMER ONE | Beacon Laboratories, Inc. | Sep 15, 1989 | SESE |
| K884175 | #820/821 BIPOLAR FORCEPS | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE |
| K884174 | MODIFIED OLSEN 755/756 SWITCHPENS | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE |
| K884173 | #920 DISPOSABLE TUR CABLE | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE |
| K884172 | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE |
| K884171 | #875 DISPOSABLE BIOPOLAR CABLE | Olsen Electrosurgical, Inc. | Oct 24, 1988 | SESE |
| K871435 | BARD EMS SYSTEM 6000 E.S.U. | C.R. Bard, Inc. | May 11, 1987 | SESE |
| K863091 | BICORD BY QMED | Qmed, Inc. | Aug 29, 1986 | SESE |
| K853291 | GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 | Bio-Detek, Inc. | Oct 10, 1985 | SESE |
Top Applicants
- Olsen Electrosurgical, Inc. — 5 clearances
- Beacon Laboratories, Inc. — 4 clearances
- Edward Weck, Inc. — 2 clearances
- Medical Products Development, Inc. — 2 clearances
- Bergen Mfg. — 1 clearance
