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FDA 510(k)

AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*

K-Number: K904931 · 1991-01-29

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1991-01-29
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE(R) PERMANENT PURSTRING(TM) 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 1991-01-29 under 510(k) number K904931. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*?

AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* is a medical device that received FDA 510(k) clearance on 1991-01-29. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K904931.

When did AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* receive FDA 510(k) clearance?

AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* received FDA 510(k) clearance on 1991-01-29, under 510(k) number K904931.

Who is the listed applicant for AUTO SUTURE(R) PERMANENT PURSTRING(TM) 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(R) PERMANENT PURSTRING(TM) APPLIER*?

The FDA product code for AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* is GAR.

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

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Related Devices (Code: GAR)

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.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.

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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