Cleared Traditional

K991400 - PARIETENE POLYPROPYLENE MESH

K991400 is the FDA 510(k) clearance for PARIETENE POLYPROPYLENE MESH by Sofradim Production. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K991400 · Sofradim Production · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
81d
Days
Class 2
Risk

K991400 is an FDA 510(k) clearance for the PARIETENE POLYPROPYLENE MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Sofradim Production (Ayer, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 81 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 Sofradim Production devices

Submission Details

510(k) Number K991400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1999
Decision Date July 12, 1999
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
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 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K991400.
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
K000185 · W.L. Gore & Associates, Inc. · Feb 2000
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
K992991 · Atrium Medical Corp. · Jan 2000
GORE-TEX DUALMESH BIOMATERIAL
K992189 · W.L. Gore & Associates, Inc. · Jul 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K984220 · Ethicon, Inc. · Feb 1999
MESH, SURGICAL, POLYMERIC
K982575 · United States Surgical, A Division of Tyco Healthc · Nov 1998
MENTOR SUSPEND SLING
K980483 · Mentor Corp. · Apr 1998