Cleared Traditional

SUPPLE PERI-GUARD (K923657) - FDA 510(k) Clearance

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

K923657 · Bio-Vascular, Inc. · General & Plastic Surgery device
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Dec 1992
Decision
208d
Days
Class 2
Risk

K923657 is an FDA 510(k) clearance for the SUPPLE PERI-GUARD. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 21, 1992 after a review of 208 days - an extended review 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: 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 Bio-Vascular, Inc. devices

Submission Details

510(k) Number K923657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date December 21, 1992
Days to Decision 208 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 115d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 37
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K923657.
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K030782 · W.L. Gore & Associates, Inc. · Apr 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc. · Dec 2000
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K982330 · Depuy, Inc. · Sep 1998
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
K915774 · Ethicon, Inc. · Mar 1992
GORE-TEX SURGICAL TAPE
K894580 · W.L. Gore & Associates, Inc. · Oct 1989
VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH
K851086 · Ethicon, Inc. · May 1985