FDA 510(k)

LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.

K-Number: K965162 · 1997-02-12

Decision Date1997-02-12

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. 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 1997-02-12 under 510(k) number K965162. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.?

LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. is a medical device that received FDA 510(k) clearance on 1997-02-12. The listed applicant is Lukens Medical Corp.. The 510(k) number is K965162.

When did LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. receive FDA 510(k) clearance?

LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. received FDA 510(k) clearance on 1997-02-12, under 510(k) number K965162.

Who is the listed applicant for LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.?

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 PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.?

The FDA product code for LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. is GAM.

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Other records listing Lukens Medical Corp. as applicant

K930945BRAIDED POLYESTER SURGICAL SUTURE K930942LUKENS SILK SURGICAL SUTURE K930943LUKENS NYLON SURGICAL SUTURE K930944LUKENS SURGICAL GUT SUTURE K930940LUKENS STAINLESS STEEL SURGICAL SUTURE K930941LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE

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Related Devices (Code: GAM)

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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.