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FDA 510(k)

SUPERSTITCH

K-Number: K994087 · 2000-03-01

ApplicantSutura, Inc.
Decision Date2000-03-01
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUPERSTITCH is the device name listed in this FDA 510(k) record. The listed applicant is Sutura, Inc.. It received FDA 510(k) clearance on 2000-03-01 under 510(k) number K994087. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERSTITCH?

SUPERSTITCH is a medical device that received FDA 510(k) clearance on 2000-03-01. The listed applicant is Sutura, Inc.. The 510(k) number is K994087.

When did SUPERSTITCH receive FDA 510(k) clearance?

SUPERSTITCH received FDA 510(k) clearance on 2000-03-01, under 510(k) number K994087.

Who is the listed applicant for SUPERSTITCH?

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?

The FDA product code for SUPERSTITCH is OCW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 06-25-00XK012865SUPERSTITCH VASCULAR SUTURING DEVICE

Related Devices (Code: OCW)

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.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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