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FDA 510(k)

OMNISURE URETHRAL SLING, MODEL OTK52

K-Number: K092203 · 2009-08-12

ApplicantMpathy Medical Devices, Ltd.
Decision Date2009-08-12
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNISURE URETHRAL SLING, MODEL OTK52 is the device name listed in this FDA 510(k) record. The listed applicant is Mpathy Medical Devices, Ltd.. It received FDA 510(k) clearance on 2009-08-12 under 510(k) number K092203. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNISURE URETHRAL SLING, MODEL OTK52?

OMNISURE URETHRAL SLING, MODEL OTK52 is a medical device that received FDA 510(k) clearance on 2009-08-12. The listed applicant is Mpathy Medical Devices, Ltd.. The 510(k) number is K092203.

When did OMNISURE URETHRAL SLING, MODEL OTK52 receive FDA 510(k) clearance?

OMNISURE URETHRAL SLING, MODEL OTK52 received FDA 510(k) clearance on 2009-08-12, under 510(k) number K092203.

Who is the listed applicant for OMNISURE URETHRAL SLING, MODEL OTK52?

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

What is the FDA product code for OMNISURE URETHRAL SLING, MODEL OTK52?

The FDA product code for OMNISURE URETHRAL SLING, MODEL OTK52 is OTN.

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 Mpathy Medical Devices, Ltd. 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.

K091180MINITAPE URETHRAL SLINGK073647MINITAPE EXTRA URETHRAL SLINGK073646MINITAPE URETHRAL SLINGK053361MODIFICATION TO: MINIMESH POLYPROPYLENE MESHK041632MINIMESH POLYPROPYLENE MESH

Related Devices (Code: OTN)

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.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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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