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FDA 510(k)

SUPERSTITCH VASCULAR SUTURING DEVICE

K-Number: K012865 · 2001-09-25

ApplicantSutura, Inc.
Decision Date2001-09-25
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPERSTITCH VASCULAR SUTURING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sutura, Inc.. It received FDA 510(k) clearance on 2001-09-25 under 510(k) number K012865. 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 SUPERSTITCH VASCULAR SUTURING DEVICE?

SUPERSTITCH VASCULAR SUTURING DEVICE is a medical device that received FDA 510(k) clearance on 2001-09-25. The listed applicant is Sutura, Inc.. The 510(k) number is K012865.

When did SUPERSTITCH VASCULAR SUTURING DEVICE receive FDA 510(k) clearance?

SUPERSTITCH VASCULAR SUTURING DEVICE received FDA 510(k) clearance on 2001-09-25, under 510(k) number K012865.

Who is the listed applicant for SUPERSTITCH VASCULAR SUTURING DEVICE?

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

What is the FDA product code for SUPERSTITCH VASCULAR SUTURING DEVICE?

The FDA product code for SUPERSTITCH VASCULAR SUTURING DEVICE 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 Sutura, 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.

K062125SUPERSTITCH 5F, 12F, AND ELK053482SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GWK020940SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00XK994087SUPERSTITCH

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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