Cleared Traditional

K792494 - CATHETERIZATION FORCEP

K792494 is the FDA 510(k) clearance for CATHETERIZATION FORCEP by C. Intl.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K792494 · C. Intl. · General & Plastic Surgery device
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Dec 1979
Decision
16d
Days
Class 1
Risk

K792494 is an FDA 510(k) clearance for the CATHETERIZATION FORCEP. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by C. Intl. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1979 after a review of 16 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 C. Intl. devices

Submission Details

510(k) Number K792494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1979
Decision Date December 20, 1979
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 57
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K792494.
BIOPSY FORCEPS W/OVAL CUP & NEEDLE
K820980 · Mill-Rose Laboratory · Apr 1982
PLASTIC FORCEPS CAT.#1001-1010
K801991 · Pollak (Intl.), Ltd. · Sep 1980
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
C RING CLINCHER
K781446 · Orthopedic Equipment Co., Inc. · Sep 1978