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FDA 510(k)

POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING

K-Number: K063536 · 2007-01-29

ApplicantTyco Healthcare Group
Decision Date2007-01-29
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare Group. It received FDA 510(k) clearance on 2007-01-29 under 510(k) number K063536. 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 POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING?

POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING is a medical device that received FDA 510(k) clearance on 2007-01-29. The listed applicant is Tyco Healthcare Group. The 510(k) number is K063536.

When did POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING receive FDA 510(k) clearance?

POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING received FDA 510(k) clearance on 2007-01-29, under 510(k) number K063536.

Who is the listed applicant for POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING?

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

What is the FDA product code for POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING?

The FDA product code for POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING is GAM.

Related Clinical Trials

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Other records listing Tyco Healthcare Group 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.

K060509PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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