Cleared Traditional

K931492 - LAPRA-TY* SUTURE CLIP

K931492 is the FDA 510(k) clearance for LAPRA-TY* SUTURE 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 152-day FDA review.

K931492 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
152d
Days
Class 2
Risk

K931492 is an FDA 510(k) clearance for the LAPRA-TY* SUTURE CLIP. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on August 24, 1993 after a review of 152 days - an extended review 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: 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 K931492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1993
Decision Date August 24, 1993
Days to Decision 152 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 115d · This submission: 152d
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 K931492.
IMPLANTABLE CLIP
K950540 · United States Surgical, A Division of Tyco Healthc · Apr 1995
IMPLANTABLE CLIP APPLIER
K934087 · United States Surgical, A Division of Tyco Healthc · Dec 1993
IMPLANTABLE CLIP
K933887 · United States Surgical, A Division of Tyco Healthc · Nov 1993
ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER
K920847 · Ethicon, Inc. · May 1992
AUTO SUTURE MODIFIED POLYMER SKIN GRAFT STAPLE
K915151 · United States Surgical, A Division of Tyco Healthc · Jan 1992
HEMOCLIP II
K911915 · Edward Weck, Inc. · Jan 1992