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FDA 510(k)

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)

K-Number: K002172 · 2001-08-28

ApplicantXiros Plc
Decision Date2001-08-28
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) is the device name listed in this FDA 510(k) record. The listed applicant is Xiros Plc. It received FDA 510(k) clearance on 2001-08-28 under 510(k) number K002172. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)?

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) is a medical device that received FDA 510(k) clearance on 2001-08-28. The listed applicant is Xiros Plc. The 510(k) number is K002172.

When did POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) receive FDA 510(k) clearance?

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) received FDA 510(k) clearance on 2001-08-28, under 510(k) number K002172.

Who is the listed applicant for POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)?

The FDA 510(k) record lists Xiros Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)?

The FDA product code for POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) is GAT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Xiros Plc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010051POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

Related Devices (Code: GAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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