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FDA 510(k)

POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE

K-Number: K042141 · 2004-09-28

ApplicantTeleflex Medical
Decision Date2004-09-28
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2004-09-28 under 510(k) number K042141. 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 POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE?

POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2004-09-28. The listed applicant is Teleflex Medical. The 510(k) number is K042141.

When did POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE receive FDA 510(k) clearance?

POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE received FDA 510(k) clearance on 2004-09-28, under 510(k) number K042141.

Who is the listed applicant for POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE?

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

What is the FDA product code for POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE?

The FDA product code for POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE is GAM.

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Related Devices (Code: GAM)

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ 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

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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