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FDA 510(k)

VESITEC SUTURE PASSER

K-Number: K931181 · 1993-05-12

ApplicantVesitec Medical, Inc.
Decision Date1993-05-12
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VESITEC SUTURE PASSER is the device name listed in this FDA 510(k) record. The listed applicant is Vesitec Medical, Inc.. It received FDA 510(k) clearance on 1993-05-12 under 510(k) number K931181. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VESITEC SUTURE PASSER?

VESITEC SUTURE PASSER is a medical device that received FDA 510(k) clearance on 1993-05-12. The listed applicant is Vesitec Medical, Inc.. The 510(k) number is K931181.

When did VESITEC SUTURE PASSER receive FDA 510(k) clearance?

VESITEC SUTURE PASSER received FDA 510(k) clearance on 1993-05-12, under 510(k) number K931181.

Who is the listed applicant for VESITEC SUTURE PASSER?

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

What is the FDA product code for VESITEC SUTURE PASSER?

The FDA product code for VESITEC SUTURE PASSER is KOA.

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 Vesitec Medical, 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.

K932925BONE ANCHOR FOR SOFT TISSUE ATTACHMENTK931182VESITEC DRILL GUIDE

Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K921304DDV LIGATORNorth American Medical, Inc.K922971NO-SCALPEL VASCETOMY INSTRUMENTSPilling Co.

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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