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

Name: FDA 510(k) clearance K002172
Creator: U.S. Food and Drug Administration
Published: 2001-08-28

Substantially Equivalent

Xiros Plc

FDA 510(k) clearance K002172 for POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS), Substantially Equivalent on 2001-08-28. Applicant: Xiros Plc. Device class: 2.

Clearance details

Applicant: Xiros Plc
Product code: Code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2000-07-19
Decision date: 2001-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAT

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K261021 — EasyWhip Family2026-07-01
K260775 — Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape2026-05-06
K254275 — HyperSuture All Green Extension Line2026-03-23
K254188 — Meniscus Versaflex2026-02-19

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K010051 — POLY-TAPES WITH THE FASTLOK FIXATION DEVICE2001-07-13

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.