FDA 510(k)

SMITH & NEPHEW ULTRABRAID SUTURE

K-Number: K041216 · 2004-06-07

Decision Date2004-06-07

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW ULTRABRAID SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2004-06-07 under 510(k) number K041216. 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 & NEPHEW ULTRABRAID SUTURE?

SMITH & NEPHEW ULTRABRAID SUTURE is a medical device that received FDA 510(k) clearance on 2004-06-07. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K041216.

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

SMITH & NEPHEW ULTRABRAID SUTURE received FDA 510(k) clearance on 2004-06-07, under 510(k) number K041216.

Who is the listed applicant for SMITH & NEPHEW ULTRABRAID SUTURE?

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

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

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

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Other records listing Smith & Nephew, Inc. as applicant

K261462LANDMARK Total Knee System K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: GAT)

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC K254275HyperSuture All Green Extension LineThreadstone, LLC K254188Meniscus 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.