Cleared Traditional

K942583 - PERI-STRIPS PLANAR CONFIGURATION STAPLE...

K942583 is an FDA 510(k) clearance for PERI-STRIPS PLANAR CONFIGURATION STAPLE..., manufactured by Bio-Vascular, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 37-day FDA review.

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

FDA 510(k) Submission Details - K942583

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
Combination Product No
PCCP Authorized No
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.

FTL Device Classification - Class 2, Special Controls

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 198
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K942583.
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899 · W.L. Gore & Associates, Inc. · Feb 1995
TRELEX NATURAL(R) MESH
K945377 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1994
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
ATRIUM POLYPROPYLENE MESH
K930669 · Atrium Medical Corp. · Dec 1993