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FDA 510(k)

SUTRASILK SILK SUTURE

K-Number: K994177 · 2000-02-08

ApplicantVisionary Medical Supplies, Inc.
Decision Date2000-02-08
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTRASILK SILK SUTURE 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 2000-02-08 under 510(k) number K994177. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTRASILK SILK SUTURE?

SUTRASILK SILK SUTURE is a medical device that received FDA 510(k) clearance on 2000-02-08. The listed applicant is Visionary Medical Supplies, Inc.. The 510(k) number is K994177.

When did SUTRASILK SILK SUTURE receive FDA 510(k) clearance?

SUTRASILK SILK SUTURE received FDA 510(k) clearance on 2000-02-08, under 510(k) number K994177.

Who is the listed applicant for SUTRASILK SILK SUTURE?

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 SUTRASILK SILK SUTURE?

The FDA product code for SUTRASILK SILK SUTURE is GAP.

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 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.

K102592SUTRAZORBK070243SUTRALENE POLYPROPYLENE SUTURESK994176SUTRALON NYLON SUTURES

Related Devices (Code: GAP)

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.

K241486Sofsilk™ Coated Braided Silk SutureCovidienK222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.

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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