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FDA 510(k)

NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

K-Number: K010909 · 2001-04-09

ApplicantTyco Healthcare Group LP
Decision Date2001-04-09
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2001-04-09 under 510(k) number K010909. 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 NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE?

NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2001-04-09. The listed applicant is Tyco Healthcare Group LP. The 510(k) number is K010909.

When did NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE receive FDA 510(k) clearance?

NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE received FDA 510(k) clearance on 2001-04-09, under 510(k) number K010909.

Who is the listed applicant for NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE?

The FDA 510(k) record lists Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE?

The FDA product code for NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE is GAW.

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Other records listing Tyco Healthcare Group LP 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.

K080898AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENTK071371COPA AMD ANTIMICROBIAL WOUND DRESSINGK060649GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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