Cleared Traditional

K854916 - PILLING HEMOSTATIC CLIP APPLIER FORCEPS

K854916 is the FDA 510(k) clearance for PILLING HEMOSTATIC CLIP APPLIER FORCEPS by Pilling Co.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K854916 · Pilling Co. · General & Plastic Surgery device
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Jan 1986
Decision
46d
Days
Class 1
Risk

K854916 is an FDA 510(k) clearance for the PILLING HEMOSTATIC CLIP APPLIER FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on January 24, 1986 after a review of 46 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 Pilling Co. devices

Submission Details

510(k) Number K854916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1985
Decision Date January 24, 1986
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
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 31
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K854916.
TISSUE FORCEPS, VARIOUS TYPES
K891896 · Zinnanti Surgical Instruments, Inc. · Apr 1989
HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT
K891401 · Zinnanti Surgical Instruments, Inc. · Apr 1989
2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS
K851728 · Artiberia · Jul 1985
15-490 TO 15-520 VARIOUS SPLINTER FORCEPS PEET, ST
K851771 · Artiberia · Jun 1985
17-100,17-272 VARIOUS HAEMOSTATIC FORCEPS
K851772 · Artiberia · Jun 1985
17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI
K851773 · Artiberia · Jun 1985