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FDA 510(k)

MONOFILAMENT BIOSYN SUTURE

K-Number: K000037 · 2000-03-30

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date2000-03-30
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOFILAMENT BIOSYN 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 2000-03-30 under 510(k) number K000037. 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 MONOFILAMENT BIOSYN SUTURE?

MONOFILAMENT BIOSYN SUTURE is a medical device that received FDA 510(k) clearance on 2000-03-30. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K000037.

When did MONOFILAMENT BIOSYN SUTURE receive FDA 510(k) clearance?

MONOFILAMENT BIOSYN SUTURE received FDA 510(k) clearance on 2000-03-30, under 510(k) number K000037.

Who is the listed applicant for MONOFILAMENT BIOSYN 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 MONOFILAMENT BIOSYN SUTURE?

The FDA product code for MONOFILAMENT BIOSYN 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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