Cleared Traditional

ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH (K030631) - FDA 510(k) Clearance

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

K030631 · Prosurg, Inc. · General & Plastic Surgery device
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May 2003
Decision
80d
Days
Class 2
Risk

K030631 is an FDA 510(k) clearance for the ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Prosurg, Inc. (San Jose, US). The FDA issued a Cleared decision on May 19, 2003 after a review of 80 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 Prosurg, Inc. devices

Submission Details

510(k) Number K030631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2003
Decision Date May 19, 2003
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 96
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K030631.
ULTRAPRO MESH
K033337 · Ethicon, Inc. · Apr 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
K033814 · C.R. Bard, Inc. · Mar 2004
PROCEED TRILAMINATE SURGICAL MESH
K031925 · Ethicon, Inc. · Sep 2003
SMALL BARD VENTRALEX PATCH
K024008 · C.R. Bard, Inc. · Feb 2003
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · C.R. Bard, Inc. · Aug 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K021736 · C.R. Bard, Inc. · Jul 2002