Cleared Traditional

K813245 - O'CONNOR HOOK PUNCH FORCEP

K813245 is an FDA 510(k) clearance for O'CONNOR HOOK PUNCH FORCEP, manufactured by Shutt Instruments. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K813245 · Shutt Instruments · General & Plastic Surgery device
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Dec 1981
Decision
41d
Days
Class 1
Risk

K813245 is an FDA 510(k) clearance for the O'CONNOR HOOK PUNCH FORCEP. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Shutt Instruments (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 41 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 Shutt Instruments devices

FDA 510(k) Submission Details - K813245

510(k) Number K813245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1981
Decision Date December 29, 1981
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

GEN Device Classification - Class 1, General Controls

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 69
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K813245.
RETRIEVAL FORCEPS W/RATTOOTHED JAWS
K820970 · Mill-Rose Laboratory · Apr 1982
BIOPSY FORCEPS W/OVAL CUPS
K820972 · Mill-Rose Laboratory · Apr 1982
BIOPSY FORCEPS W/OVAL CUP & NEEDLE
K820980 · Mill-Rose Laboratory · Apr 1982
VANCE-AMBROSE RESECTOSCOPE FORCEPS
K812785 · Vance Products, Inc. · Nov 1981
PLASTIC FORCEPS CAT.#1001-1010
K801991 · Pollak (Intl.), Ltd. · Sep 1980
NORSEN DEBRIDER
K800647 · Medline Industries, Inc. · Apr 1980