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FDA 510(k)

AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER

K-Number: K972911 · 1998-04-25

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1998-04-25
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1998-04-25 under 510(k) number K972911. 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 AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER?

AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER is a medical device that received FDA 510(k) clearance on 1998-04-25. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K972911.

When did AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER receive FDA 510(k) clearance?

AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER received FDA 510(k) clearance on 1998-04-25, under 510(k) number K972911.

Who is the listed applicant for AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER?

The FDA product code for AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER is GAT.

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Other records listing United States Surgical, A Division of Tyco Healthc 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.

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERK071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORK061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERK062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSK062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEK061095AUTO SUTUR ENDO GIA STAPLERS

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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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