Cleared Special

NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)

K993306 · Paladin Medical, Inc. · General & Plastic Surgery
Nov 1999
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K993306 is an FDA 510(k) clearance for the NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY), a Apparatus, Electrosurgical (Class II — Special Controls, product code HAM), submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 3, 1999, 30 days after receiving the submission on October 4, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K993306 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1999
Decision Date November 03, 1999
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code HAM — Apparatus, Electrosurgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400