Cleared Traditional

PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT (K942583) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942583 · Bio-Vascular, Inc. · General & Plastic Surgery device
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Jul 1994
Decision
37d
Days
Class 2
Risk

K942583 is an FDA 510(k) clearance for the PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 8, 1994 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 Bio-Vascular, Inc. devices

Submission Details

510(k) Number K942583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1994
Decision Date July 08, 1994
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTL Mesh, Surgical, Polymeric

All 131
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K942583.
GORE-TEX MYCROMESH PLUS BIOMATERIAL
K946107 · W.L. Gore & Associates, Inc. · Apr 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899 · W.L. Gore & Associates, Inc. · Feb 1995
GORE-TEX SOFT TISSUE PATCH PLUS
K922452 · W.L. Gore & Associates, Inc. · Sep 1994
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
K930822 · W.L. Gore & Associates, Inc. · Jan 1994
GIANTURCO-HELFRICH HERNIS MESH
K931936 · Cook, Inc. · Jan 1994
GORE-TEK(R) SOFT TISSUE PATCH
K926478 · W.L. Gore & Associates, Inc. · Nov 1993