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FDA 510(k)

AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*

K-Number: K910586 · 1991-03-07

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1991-03-07
Product CodeGDT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* 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 1991-03-07 under 510(k) number K910586. The device is classified under product code GDT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*?

AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* is a medical device that received FDA 510(k) clearance on 1991-03-07. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K910586.

When did AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* receive FDA 510(k) clearance?

AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* received FDA 510(k) clearance on 1991-03-07, under 510(k) number K910586.

Who is the listed applicant for AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*?

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) POLYMER SKIN GRAFT STAPLER*?

The FDA product code for AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* is GDT.

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

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Related Devices (Code: GDT)

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.

K963234STAPLE REMOVAL KITContinental Medical Laboratories, Inc.K943719VISISTAT STAPLERPilling Weck, Inc.K925526MANIPLER DISPOSABLE SKIN STAPLERMatsutani Seisakusho Co. , Ltd.K915430SKIN STAPLE REMOVER KITCypress Medical Products, Ltd.K911204QUALTEX SKIN STAPLE EXTRACTORDeroyal Industries, Inc.K900486APPOSE UNITY STERILE DISPOSABLE SKIN STAPLERDavis & Geck, 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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