Cleared Traditional

FORCEPS, BIOPSY(NON RIGID) (K852120) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

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

K852120 is an FDA 510(k) clearance for the FORCEPS, BIOPSY(NON RIGID). Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Scholten Surgical Instruments, Inc. (Redwood City, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scholten Surgical Instruments, Inc. devices

Submission Details

510(k) Number K852120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEN Forceps, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GEN Forceps, General & Plastic Surgery

All 8
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K852120.
NORSEN DEBRIDER
K800647 · Medline Industries, Inc. · Apr 1980
CASTROVIEJO VASCULAR NEEDLEHOLDER 538425
K792309 · Edward Weck, Inc. · Nov 1979
VASCULAR FORCEPS & CLAMPS
K791987 · Edward Weck, Inc. · Oct 1979
CARROLL TENDON RETRIEVER
K772393 · Edward Weck, Inc. · May 1978
LONG JEWELERS FORCEPS
K772383 · Edward Weck, Inc. · Mar 1978
SUTURE TISSUE APPROXIMATING FORCEP
K771515 · United States Surgical, A Division of Tyco Healthc · Sep 1977