HAM — Apparatus, Electrosurgical Class II
FDA product code HAM covers "Apparatus, Electrosurgical", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HAM
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K153472 | itl corporation pty | Quiver Laparoscopic Extendable | June 23, 2016 |
| K000079 | nikomed u.s.a | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | February 4, 2000 |
| K993306 | paladin medical | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 | November 3, 1999 |
| K945861 | bergen mfg | BERGEN 710 ESU | March 1, 1995 |
| K913300 | cook ob/gyn | LAPAROSTAT(TM) | April 2, 1992 |
| K920100 | beacon laboratories | GSU HANDPIECE ADAPTER | February 3, 1992 |
| K911353 | emc industries | EMC MODEL NO. STATOME 900 | June 24, 1991 |
| K901248 | beacon laboratories | ABC HANDPIECE ADAPTER | April 3, 1990 |
| K881334 | nk-optik | LIGHT COAGULATOR LC 250 | November 16, 1989 |
| K894663 | beacon laboratories | BEAMER ONE | September 15, 1989 |
| K895337 | new england surgical instrument | ELECTROSURGICAL COAGULATION SUCTION TUBE | September 15, 1989 |
| K894762 | beacon laboratories | B100 DISPOSABLE HANDPIECE | September 15, 1989 |
| K884172 | olsen electrosurgical | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | October 24, 1988 |
| K884173 | olsen electrosurgical | #920 DISPOSABLE TUR CABLE | October 24, 1988 |
| K884175 | olsen electrosurgical | #820/821 BIPOLAR FORCEPS | October 24, 1988 |
| K884171 | olsen electrosurgical | #875 DISPOSABLE BIOPOLAR CABLE | October 24, 1988 |
| K884174 | olsen electrosurgical | MODIFIED OLSEN 755/756 SWITCHPENS | October 24, 1988 |
| K871435 | c.r. bard | BARD EMS SYSTEM 6000 E.S.U. | May 11, 1987 |
| K863091 | qmed | BICORD BY QMED | August 29, 1986 |
| K853291 | bio-detek | GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 | October 10, 1985 |