FDA 510(k)

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

K-Number: K991191 · 1999-06-22

ApplicantGenzyme Surgical Product (Genzyme Biosurgery)

Decision Date1999-06-22

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). It received FDA 510(k) clearance on 1999-06-22 under 510(k) number K991191. 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 BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE?

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 1999-06-22. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). The 510(k) number is K991191.

When did BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE receive FDA 510(k) clearance?

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE received FDA 510(k) clearance on 1999-06-22, under 510(k) number K991191.

Who is the listed applicant for BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE?

The FDA 510(k) record lists Genzyme Surgical Product (Genzyme Biosurgery) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE?

The FDA product code for BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE is GAM.

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Other records listing Genzyme Surgical Product (Genzyme Biosurgery) as applicant

K001440NEXTSTITCH CARDIOVASCULAR VALVE SUTURE K001434'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE K991416ENDOSCOPIC CAMERA K990062SAPHLIFT K982712RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250

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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.