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FDA 510(k)

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE

K-Number: K930941 · 1993-12-17

ApplicantLukens Medical Corp.
Decision Date1993-12-17
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE is the device name listed in this FDA 510(k) record. The listed applicant is Lukens Medical Corp.. It received FDA 510(k) clearance on 1993-12-17 under 510(k) number K930941. 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 LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE?

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is Lukens Medical Corp.. The 510(k) number is K930941.

When did LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE receive FDA 510(k) clearance?

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE received FDA 510(k) clearance on 1993-12-17, under 510(k) number K930941.

Who is the listed applicant for LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE?

The FDA 510(k) record lists Lukens Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE?

The FDA product code for LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE is GAW.

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Other records listing Lukens Medical Corp. 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.

K965162LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.K930942LUKENS SILK SURGICAL SUTUREK930943LUKENS NYLON SURGICAL SUTUREK930940LUKENS STAINLESS STEEL SURGICAL SUTUREK930944LUKENS SURGICAL GUT SUTUREK930945BRAIDED POLYESTER SURGICAL SUTURE

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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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