Cleared Traditional

K910524 - SURGICAL CLIPPER (FDA 510(k) Clearance)

Mar 1991
Decision
49d
Days
Class 1
Risk

K910524 is an FDA 510(k) clearance for the SURGICAL CLIPPER. This device is classified as a Razor, Surgical (Class I - General Controls, product code LWK).

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on March 28, 1991, 49 days after receiving the submission on February 7, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K910524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1991
Decision Date March 28, 1991
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code LWK — Razor, Surgical
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800