Cleared Traditional

K831457 - AUTO SUTURE POLY SURGICLIP HEMOSTATIC

K831457 is the FDA 510(k) clearance for AUTO SUTURE POLY SURGICLIP HEMOSTATIC by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K831457 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
94d
Days
Class 2
Risk

K831457 is an FDA 510(k) clearance for the AUTO SUTURE POLY SURGICLIP HEMOSTATIC. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Walker, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 94 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K831457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date August 08, 1983
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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 103
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K831457.
HEMOCLIP AUTOMATIC CLIPS MEDIUM
K841549 · Edward Weck, Inc. · Aug 1984
3M RAPIDSTAT LIGATING CLIP SYS
K842382 · 3M Company · Aug 1984
LIGACLIP METALLIC LIGATING CLIP
K834267 · Ethicon, Inc. · Mar 1984
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