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FDA 510(k)

LUKENS SURGICAL GUT SUTURE

K-Number: K930944 · 1993-12-17

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

Device Summary

LUKENS SURGICAL GUT SUTURE 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 K930944. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUKENS SURGICAL GUT SUTURE?

LUKENS SURGICAL GUT SUTURE 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 K930944.

When did LUKENS SURGICAL GUT SUTURE receive FDA 510(k) clearance?

LUKENS SURGICAL GUT SUTURE received FDA 510(k) clearance on 1993-12-17, under 510(k) number K930944.

Who is the listed applicant for LUKENS SURGICAL GUT SUTURE?

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 SURGICAL GUT SUTURE?

The FDA product code for LUKENS SURGICAL GUT SUTURE is GAL.

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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 SUTUREK930941LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLEK930945BRAIDED POLYESTER SURGICAL SUTURE

View all 8 devices →

Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, 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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