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FDA 510(k)

SUTRAZORB

K-Number: K102592 · 2011-02-03

ApplicantVisionary Medical Supplies, Inc.
Decision Date2011-02-03
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTRAZORB is the device name listed in this FDA 510(k) record. The listed applicant is Visionary Medical Supplies, Inc.. It received FDA 510(k) clearance on 2011-02-03 under 510(k) number K102592. 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 SUTRAZORB?

SUTRAZORB is a medical device that received FDA 510(k) clearance on 2011-02-03. The listed applicant is Visionary Medical Supplies, Inc.. The 510(k) number is K102592.

When did SUTRAZORB receive FDA 510(k) clearance?

SUTRAZORB received FDA 510(k) clearance on 2011-02-03, under 510(k) number K102592.

Who is the listed applicant for SUTRAZORB?

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

What is the FDA product code for SUTRAZORB?

The FDA product code for SUTRAZORB is GAM.

Related Clinical Trials

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Other records listing Visionary Medical Supplies, Inc. 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.

K070243SUTRALENE POLYPROPYLENE SUTURESK994176SUTRALON NYLON SUTURESK994177SUTRASILK SILK SUTURE

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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