Cleared Traditional

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (K002172) - FDA 510(k) Clearance

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

K002172 · Xiros Plc · General & Plastic Surgery device
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Aug 2001
Decision
405d
Days
Class 2
Risk

K002172 is an FDA 510(k) clearance for the POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS). Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Xiros Plc (Leeds, GB). The FDA issued a Cleared decision on August 28, 2001 after a review of 405 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 878.5000 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Xiros Plc devices

Submission Details

510(k) Number K002172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2000
Decision Date August 28, 2001
Days to Decision 405 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 115d · This submission: 405d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 74
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K002172.
LIFESTITCH SUTURING DEVICE
K013990 · Edwards Lifesciences, LLC · Feb 2002
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · Arthrex, Inc. · Oct 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · Aesculap, Inc. · Sep 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · Arthrex, Inc. · May 2001
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
K990952 · United States Surgical, A Division of Tyco Healthc · Apr 1999
PRE-THREADED ENDOBUTTON
K984550 · Smith & Nephew, Inc. · Mar 1999