Cleared Traditional

FORCEP (K812205) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K812205 · Reznik Instruments · General & Plastic Surgery device
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Oct 1981
Decision
83d
Days
Class 1
Risk

K812205 is an FDA 510(k) clearance for the FORCEP. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Reznik Instruments (Mchenry, US). The FDA issued a Cleared decision on October 26, 1981 after a review of 83 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 Reznik Instruments devices

Submission Details

510(k) Number K812205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1981
Decision Date October 26, 1981
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
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 22
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K812205.
CONPHAR ALLIS FORCEPS
K821353 · Conphar, Inc. · May 1982
TUBE OCCULDING FORCEPS 7
K821288 · Conphar, Inc. · May 1982
CONPHAR FOERSTER FORCEPS
K821349 · Conphar, Inc. · May 1982
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