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FDA 510(k)

MODIFICATION TO: MINIMESH POLYPROPYLENE MESH

K-Number: K053361 · 2006-02-06

ApplicantMpathy Medical Devices, Ltd.
Decision Date2006-02-06
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: MINIMESH POLYPROPYLENE MESH 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 2006-02-06 under 510(k) number K053361. The device is classified under product code OTO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: MINIMESH POLYPROPYLENE MESH?

MODIFICATION TO: MINIMESH POLYPROPYLENE MESH is a medical device that received FDA 510(k) clearance on 2006-02-06. The listed applicant is Mpathy Medical Devices, Ltd.. The 510(k) number is K053361.

When did MODIFICATION TO: MINIMESH POLYPROPYLENE MESH receive FDA 510(k) clearance?

MODIFICATION TO: MINIMESH POLYPROPYLENE MESH received FDA 510(k) clearance on 2006-02-06, under 510(k) number K053361.

Who is the listed applicant for MODIFICATION TO: MINIMESH POLYPROPYLENE MESH?

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 MODIFICATION TO: MINIMESH POLYPROPYLENE MESH?

The FDA product code for MODIFICATION TO: MINIMESH POLYPROPYLENE MESH is OTO.

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 OTK52K091180MINITAPE URETHRAL SLINGK073647MINITAPE EXTRA URETHRAL SLINGK073646MINITAPE URETHRAL SLINGK041632MINIMESH POLYPROPYLENE MESH

Related Devices (Code: OTO)

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.

K171271Polyform Synthetic MeshBoston Scientific CorporationK132061RESTORELLE M, RESTORELLE XLColoplast Corp.K123028VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHCaldera Medical, Inc.K123914RESTORELLE Y CONTOURColoplast A/SK123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMCaldera MedicalK122794UPSYLON Y MESHBoston Scientific Corp

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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