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FDA 510(k)

TUFFLEX POLYESTER SUTURE

K-Number: K063194 · 2006-12-04

ApplicantAxya Medical, Inc.
Decision Date2006-12-04
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TUFFLEX POLYESTER SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Axya Medical, Inc.. It received FDA 510(k) clearance on 2006-12-04 under 510(k) number K063194. 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 TUFFLEX POLYESTER SUTURE?

TUFFLEX POLYESTER SUTURE is a medical device that received FDA 510(k) clearance on 2006-12-04. The listed applicant is Axya Medical, Inc.. The 510(k) number is K063194.

When did TUFFLEX POLYESTER SUTURE receive FDA 510(k) clearance?

TUFFLEX POLYESTER SUTURE received FDA 510(k) clearance on 2006-12-04, under 510(k) number K063194.

Who is the listed applicant for TUFFLEX POLYESTER SUTURE?

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

What is the FDA product code for TUFFLEX POLYESTER SUTURE?

The FDA product code for TUFFLEX POLYESTER SUTURE is GAT.

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Other records listing Axya Medical, Inc. 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.

K070773AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHORK070253AXYA SUTURE WELDING SYSTEM AND KITK060165AXYAFLEX POLYESTER SUTUREK060970AXYALOOP NONABSORBABLE BONE ANCHORK052491AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHORK051983MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

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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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