Cleared Traditional

K982575 - MESH, SURGICAL, POLYMERIC

K982575 is an FDA 510(k) clearance for MESH, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K982575 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
105d
Days
Class 2
Risk

K982575 is an FDA 510(k) clearance for the MESH, SURGICAL, POLYMERIC. 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 November 6, 1998 after a review of 105 days - within the typical 510(k) review window.

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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K982575

510(k) Number K982575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1998
Decision Date November 06, 1998
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 315
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K982575.
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K984220 · Ethicon, Inc. · Feb 1999
PARIETEX
K982532 · Cogent · Jan 1999
FLUOROTEX SURGICAL MESH
K984197 · Bridger Biomed, Inc. · Jan 1999
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
K982475 · Tissue Technologies, Inc. · Sep 1998
SHELHIGH NO-REACT PNEUMOPLEDGETS
K981756 · Shelhigh, Inc. · Aug 1998
SIS HERNIA REPAIR DEVICE
K974540 · Sentron Medical, Inc. · May 1998