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FDA 510(k)

SMITH & NEWPHEW ULTRABRAID II SUTURE

K-Number: K101377 · 2011-04-08

ApplicantSmith & Newphew, Inc.
Decision Date2011-04-08
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMITH & NEWPHEW ULTRABRAID II SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Newphew, Inc.. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K101377. 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 SMITH & NEWPHEW ULTRABRAID II SUTURE?

SMITH & NEWPHEW ULTRABRAID II SUTURE is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Smith & Newphew, Inc.. The 510(k) number is K101377.

When did SMITH & NEWPHEW ULTRABRAID II SUTURE receive FDA 510(k) clearance?

SMITH & NEWPHEW ULTRABRAID II SUTURE received FDA 510(k) clearance on 2011-04-08, under 510(k) number K101377.

Who is the listed applicant for SMITH & NEWPHEW ULTRABRAID II SUTURE?

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

What is the FDA product code for SMITH & NEWPHEW ULTRABRAID II SUTURE?

The FDA product code for SMITH & NEWPHEW ULTRABRAID II SUTURE is GAT.

Related Clinical Trials

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Other records listing Smith & Newphew, 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.

K102967SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2

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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