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FDA 510(k)

MINITAPE URETHRAL SLING

K-Number: K091180 · 2009-07-14

ApplicantMpathy Medical Devices, Ltd.
Decision Date2009-07-14
Product CodePAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MINITAPE URETHRAL SLING 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 2009-07-14 under 510(k) number K091180. The device is classified under product code PAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINITAPE URETHRAL SLING?

MINITAPE URETHRAL SLING is a medical device that received FDA 510(k) clearance on 2009-07-14. The listed applicant is Mpathy Medical Devices, Ltd.. The 510(k) number is K091180.

When did MINITAPE URETHRAL SLING receive FDA 510(k) clearance?

MINITAPE URETHRAL SLING received FDA 510(k) clearance on 2009-07-14, under 510(k) number K091180.

Who is the listed applicant for MINITAPE URETHRAL SLING?

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 MINITAPE URETHRAL SLING?

The FDA product code for MINITAPE URETHRAL SLING is PAH.

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.

K092203OMNISURE URETHRAL SLING, MODEL OTK52K073647MINITAPE EXTRA URETHRAL SLINGK073646MINITAPE URETHRAL SLINGK053361MODIFICATION TO: MINIMESH POLYPROPYLENE MESHK041632MINIMESH POLYPROPYLENE MESH

Related Devices (Code: PAH)

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.

K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)Coloplast Corp.K221874Altis Single Incision Sling SystemColoplast A/SK191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc.K121562ALTIS SINGLE INCISION CLING SYSTEMColoplast A/SK123179AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLINGC.R. Bard, Inc.K121641MINIARC PRO SINGLE-INCISION SLING SYSTEMAmerican Medical Systems

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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