Cleared Traditional

K933827 - BIOSIL MEDICAL GRADE SILICONE SHEETING ...

K933827 is an FDA 510(k) clearance for BIOSIL MEDICAL GRADE SILICONE SHEETING ..., manufactured by Bioplexus Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K933827 · Bioplexus Corp. · General & Plastic Surgery device
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Jun 1994
Decision
329d
Days
Class 2
Risk

K933827 is an FDA 510(k) clearance for the BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Bioplexus Corp. (Las Vegas, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bioplexus Corp. devices

FDA 510(k) Submission Details - K933827

510(k) Number K933827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1993
Decision Date June 30, 1994
Days to Decision 329 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
214d slower than avg
Panel avg: 115d · This submission: 329d
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 190
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K933827.
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