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FDA 510(k)

SUTRALENE POLYPROPYLENE SUTURES

K-Number: K070243 · 2007-04-17

ApplicantVisionary Medical Supplies, Inc.
Decision Date2007-04-17
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTRALENE POLYPROPYLENE SUTURES 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 2007-04-17 under 510(k) number K070243. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTRALENE POLYPROPYLENE SUTURES?

SUTRALENE POLYPROPYLENE SUTURES is a medical device that received FDA 510(k) clearance on 2007-04-17. The listed applicant is Visionary Medical Supplies, Inc.. The 510(k) number is K070243.

When did SUTRALENE POLYPROPYLENE SUTURES receive FDA 510(k) clearance?

SUTRALENE POLYPROPYLENE SUTURES received FDA 510(k) clearance on 2007-04-17, under 510(k) number K070243.

Who is the listed applicant for SUTRALENE POLYPROPYLENE SUTURES?

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 SUTRALENE POLYPROPYLENE SUTURES?

The FDA product code for SUTRALENE POLYPROPYLENE SUTURES is GAW.

Related Clinical Trials

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.

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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.

K102592SUTRAZORBK994177SUTRASILK SILK SUTUREK994176SUTRALON NYLON SUTURES

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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