Cleared Traditional

K811935 - PROLENE POLYPROPYLENE LIGATING CLIP

K811935 is the FDA 510(k) clearance for PROLENE POLYPROPYLENE 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 67-day FDA review.

K811935 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1981
Decision
67d
Days
Class 2
Risk

K811935 is an FDA 510(k) clearance for the PROLENE POLYPROPYLENE LIGATING CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1981 after a review of 67 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 K811935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1981
Decision Date September 11, 1981
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
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 K811935.
LIGACLIP TITANIUM LIGATING CLIP
K830503 · Ethicon, Inc. · Mar 1983
MULTICLIP DISP. LIGATING CLIP DEVICE
K820999 · Davis & Geck, Inc. · May 1982
PDS* ABSORBABLE LIGATING CLIPS
K812323 · Ethicon, Inc. · Nov 1981
NYLON LIGATING CLIP
K801124 · Ethicon, Inc. · Jun 1980
HEMOCLIP SURGICAL OCCLUDING CLIP
K800079 · Edward Weck, Inc. · Jan 1980
LIGACLIP MULTIPLE LIGATING CLIPS
K771413 · Ethicon, Inc. · Nov 1977