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FDA 510(k)

MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE

K-Number: K050947 · 2005-06-01

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date2005-06-01
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE 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 2005-06-01 under 510(k) number K050947. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE?

MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE is a medical device that received FDA 510(k) clearance on 2005-06-01. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K050947.

When did MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE receive FDA 510(k) clearance?

MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE received FDA 510(k) clearance on 2005-06-01, under 510(k) number K050947.

Who is the listed applicant for MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE?

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 MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE?

The FDA product code for MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE is GAW.

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Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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