Cleared Traditional

NONABSORBABLE POLYPROPYLENE SURGICAL MESH (K905655) - FDA 510(k) Clearance

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

K905655 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Dec 1990
Decision
13d
Days
Class 2
Risk

K905655 is an FDA 510(k) clearance for the NONABSORBABLE POLYPROPYLENE SURGICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on December 31, 1990 after a review of 13 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K905655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date December 31, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
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 130
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K905655.
BARD MARLEX MESH DART
K922916 · C.R. Bard, Inc. · Aug 1992
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
K915526 · United States Surgical, A Division of Tyco Healthc · May 1992
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE
K914449 · W.L. Gore & Associates, Inc. · Dec 1991
STERILIZATION OF GORE-TEX SOFT TISSU
K833764 · W.L. Gore & Associates, Inc. · Jan 1984
GORE-TEX TISSUE REINFORCEMENT PATCH
K820193 · W.L. Gore & Associates, Inc. · Mar 1982
VICRYL
K810428 · Ethicon, Inc. · Mar 1981