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FDA 510(k)

MODIFIED USSC* POLYSORB SUTURE

K-Number: K970863 · 1997-05-05

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1997-05-05
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODIFIED USSC* POLYSORB 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 1997-05-05 under 510(k) number K970863. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MODIFIED USSC* POLYSORB SUTURE?

MODIFIED USSC* POLYSORB SUTURE is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K970863.

When did MODIFIED USSC* POLYSORB SUTURE receive FDA 510(k) clearance?

MODIFIED USSC* POLYSORB SUTURE received FDA 510(k) clearance on 1997-05-05, under 510(k) number K970863.

Who is the listed applicant for MODIFIED USSC* POLYSORB 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 MODIFIED USSC* POLYSORB SUTURE?

The FDA product code for MODIFIED USSC* POLYSORB 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)

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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