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FDA 510(k)

FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE

K-Number: K063778 · 2007-02-09

ApplicantTeleflex Medical
Decision Date2007-02-09
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2007-02-09 under 510(k) number K063778. 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 FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE?

FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2007-02-09. The listed applicant is Teleflex Medical. The 510(k) number is K063778.

When did FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE receive FDA 510(k) clearance?

FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE received FDA 510(k) clearance on 2007-02-09, under 510(k) number K063778.

Who is the listed applicant for FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE?

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

What is the FDA product code for FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE?

The FDA product code for FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE is GAT.

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Other records listing Teleflex Medical as applicant

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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

View on FDA Database →

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

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