Cleared Traditional

K771746 - FORCEPS

K771746 is the FDA 510(k) clearance for FORCEPS by Depuy, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K771746 · Depuy, Inc. · General & Plastic Surgery device
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Sep 1977
Decision
11d
Days
Class 1
Risk

K771746 is an FDA 510(k) clearance for the FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1977 after a review of 11 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 Depuy, Inc. devices

Submission Details

510(k) Number K771746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1977
Decision Date September 26, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
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 56
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K771746.
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
ANGLED FORCEP APPLIER
K771691 · Edward Weck, Inc. · Sep 1977
WOMB PREP KIT
K770329 · American Hospital Supply Corp. · Apr 1977