Cleared Traditional

K812323 - PDS* ABSORBABLE LIGATING CLIPS

K812323 is the FDA 510(k) clearance for PDS* ABSORBABLE LIGATING CLIPS by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K812323 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
91d
Days
Class 2
Risk

K812323 is an FDA 510(k) clearance for the PDS* ABSORBABLE LIGATING CLIPS. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K812323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1981
Decision Date November 16, 1981
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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 K812323.
AUTO SUTURE POLY SURGICLIP HEMOSTATIC
K831457 · United States Surgical, A Division of Tyco Healthc · Aug 1983
LIGACLIP TITANIUM LIGATING CLIP
K830503 · Ethicon, Inc. · Mar 1983
MULTICLIP DISP. LIGATING CLIP DEVICE
K820999 · Davis & Geck, Inc. · May 1982
PROLENE POLYPROPYLENE LIGATING CLIP
K811935 · Ethicon, Inc. · Sep 1981
NYLON LIGATING CLIP
K801124 · Ethicon, Inc. · Jun 1980
HEMOCLIP SURGICAL OCCLUDING CLIP
K800079 · Edward Weck, Inc. · Jan 1980