Cleared Traditional

K772393 - CARROLL TENDON RETRIEVER

K772393 is an FDA 510(k) clearance for CARROLL TENDON RETRIEVER, manufactured by Edward Weck, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K772393 · Edward Weck, Inc. · General & Plastic Surgery device
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May 1978
Decision
133d
Days
Class 1
Risk

K772393 is an FDA 510(k) clearance for the CARROLL TENDON RETRIEVER. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1978 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Edward Weck, Inc. devices

FDA 510(k) Submission Details - K772393

510(k) Number K772393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date May 09, 1978
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 58
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K772393.
C RING CLINCHER
K781446 · Orthopedic Equipment Co., Inc. · Sep 1978
THREADED ROD CLAMP
K781447 · Orthopedic Equipment Co., Inc. · Sep 1978
HARRINGTON HOOK CLAMP
K781448 · Orthopedic Equipment Co., Inc. · Sep 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
FORCEPS
K771746 · Depuy, Inc. · Sep 1977