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FDA 510(k)

PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

K-Number: K980703 · 1998-05-04

ApplicantAesculap, Inc.
Decision Date1998-05-04
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 1998-05-04 under 510(k) number K980703. 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 PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE?

PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 1998-05-04. The listed applicant is Aesculap, Inc.. The 510(k) number is K980703.

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

PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE received FDA 510(k) clearance on 1998-05-04, under 510(k) number K980703.

Who is the listed applicant for PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL 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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