Cleared Traditional

CASTROVIEJO VASCULAR NEEDLEHOLDER 538425 (K792309) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K792309 · Edward Weck, Inc. · General & Plastic Surgery device
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Nov 1979
Decision
14d
Days
Class 1
Risk

K792309 is an FDA 510(k) clearance for the CASTROVIEJO VASCULAR NEEDLEHOLDER 538425. 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 November 30, 1979 after a review of 14 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 Edward Weck, Inc. devices

Submission Details

510(k) Number K792309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1979
Decision Date November 30, 1979
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 7
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K792309.
NORSEN DEBRIDER
K800647 · Medline Industries, Inc. · Apr 1980
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
FORCEPS
K771746 · Depuy, Inc. · Sep 1977