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FDA 510(k)

ACUFEX DOUBLE ARMED SUTURE NEEDLE

K-Number: K970416 · 1997-04-21

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date1997-04-21
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUFEX DOUBLE ARMED SUTURE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K970416. 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 ACUFEX DOUBLE ARMED SUTURE NEEDLE?

ACUFEX DOUBLE ARMED SUTURE NEEDLE is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K970416.

When did ACUFEX DOUBLE ARMED SUTURE NEEDLE receive FDA 510(k) clearance?

ACUFEX DOUBLE ARMED SUTURE NEEDLE received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970416.

Who is the listed applicant for ACUFEX DOUBLE ARMED SUTURE NEEDLE?

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

What is the FDA product code for ACUFEX DOUBLE ARMED SUTURE NEEDLE?

The FDA product code for ACUFEX DOUBLE ARMED SUTURE NEEDLE is GAT.

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Other records listing Smith & Nephew Endoscopy, 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.

K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSK102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORSK093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORK083226SMITH & NEPHEW PEEK INTERFERENCE SCREWK083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWK082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

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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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