Cleared Traditional

FORCEPS

K953962 · Biopsys Medical, Inc. · General & Plastic Surgery
Sep 1995
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K953962 is an FDA 510(k) clearance for the FORCEPS, a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), submitted by Biopsys Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on September 8, 1995, 17 days after receiving the submission on August 22, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K953962 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1995
Decision Date September 08, 1995
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEN — Forceps, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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