Cleared Traditional

K790854 - FORCEPS #101 AND #102

K790854 is the FDA 510(k) clearance for FORCEPS #101 AND #102 by C. Intl.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K790854 · C. Intl. · General & Plastic Surgery device
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Jun 1979
Decision
32d
Days
Class 1
Risk

K790854 is an FDA 510(k) clearance for the FORCEPS #101 AND #102. 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 June 5, 1979 after a review of 32 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 K790854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1979
Decision Date June 05, 1979
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 K790854.
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
THREADED ROD CLAMP
K781447 · Orthopedic Equipment Co., Inc. · Sep 1978
HARRINGTON HOOK CLAMP
K781448 · Orthopedic Equipment Co., Inc. · Sep 1978