FDA 510(k)

POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE

K-Number: K953869 · 1995-10-18

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1995-10-18

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1995-10-18 under 510(k) number K953869. 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 II COATED SYNTHETIC ABSORBABLE SUTURE?

POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 1995-10-18. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K953869.

When did POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE receive FDA 510(k) clearance?

POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE received FDA 510(k) clearance on 1995-10-18, under 510(k) number K953869.

Who is the listed applicant for POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE?

The FDA product code for POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE is GAM.

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Other records listing United States Surgical, A Division of Tyco Healthc as applicant

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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.