NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M— 510(k) K000079

Name: FDA 510(k) clearance K000079
Creator: U.S. Food and Drug Administration
Published: 2000-02-04

Substantially Equivalent

Nikomed U.S.A., Inc.

FDA 510(k) clearance K000079 for NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M, Substantially Equivalent on 2000-02-04. Applicant: Nikomed U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Nikomed U.S.A., Inc.
Product code: Code HAM
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2000-01-11
Decision date: 2000-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAM

view all

K153472 — Quiver Laparoscopic Extendable2016-06-23
K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)1999-11-03
K945861 — BERGEN 710 ESU1995-03-01
K913300 — LAPAROSTAT(TM)1992-04-02
K920100 — GSU HANDPIECE ADAPTER1992-02-03

More clearances from Nikomed U.S.A., Inc.

view all

K022909 — NIKOMED TRACE 1 ECG ELECTRODES2003-01-09
K950473 — DISPOSABLE ECG MONITORING ELECTRODE1995-12-12
K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM1995-11-14
K950475 — DISPOSABLE ECG MONITORING ELECTRODE #4530, #45401995-11-14
K950470 — DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM1995-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.