Cleared Traditional

K830503 - LIGACLIP TITANIUM LIGATING CLIP

K830503 is the FDA 510(k) clearance for LIGACLIP TITANIUM LIGATING CLIP by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K830503 · Ethicon, Inc. · General & Plastic Surgery device
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Mar 1983
Decision
20d
Days
Class 2
Risk

K830503 is an FDA 510(k) clearance for the LIGACLIP TITANIUM LIGATING CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on March 8, 1983 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 Ethicon, Inc. devices

Submission Details

510(k) Number K830503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1983
Decision Date March 08, 1983
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 96
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K830503.
3M RAPIDSTAT LIGATING CLIP SYS
K842382 · 3M Company · Aug 1984
LIGACLIP METALLIC LIGATING CLIP
K834267 · Ethicon, Inc. · Mar 1984
AUTO SUTURE POLY SURGICLIP HEMOSTATIC
K831457 · United States Surgical, A Division of Tyco Healthc · Aug 1983
MULTICLIP DISP. LIGATING CLIP DEVICE
K820999 · Davis & Geck, Inc. · May 1982
PDS* ABSORBABLE LIGATING CLIPS
K812323 · Ethicon, Inc. · Nov 1981
PROLENE POLYPROPYLENE LIGATING CLIP
K811935 · Ethicon, Inc. · Sep 1981