Cleared Traditional

FORCEPS, BIOPSY(NON RIGID)

K852120 · Scholten Surgical Instruments, Inc. · General & Plastic Surgery
Jul 1985
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K852120 is an FDA 510(k) clearance for the FORCEPS, BIOPSY(NON RIGID), a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), submitted by Scholten Surgical Instruments, Inc. (Redwood City, US). The FDA issued a Cleared decision on July 2, 1985, 48 days after receiving the submission on May 15, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K852120 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1985
Decision Date July 02, 1985
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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