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FDA 510(k)

POLYFORM SYNTHETIC MESH

K-Number: K051245 · 2005-06-17

ApplicantProxy Biomedical , Ltd.
Decision Date2005-06-17
Product CodeOTO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLYFORM SYNTHETIC MESH is the device name listed in this FDA 510(k) record. The listed applicant is Proxy Biomedical , Ltd.. It received FDA 510(k) clearance on 2005-06-17 under 510(k) number K051245. 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 POLYFORM SYNTHETIC MESH?

POLYFORM SYNTHETIC MESH is a medical device that received FDA 510(k) clearance on 2005-06-17. The listed applicant is Proxy Biomedical , Ltd.. The 510(k) number is K051245.

When did POLYFORM SYNTHETIC MESH receive FDA 510(k) clearance?

POLYFORM SYNTHETIC MESH received FDA 510(k) clearance on 2005-06-17, under 510(k) number K051245.

Who is the listed applicant for POLYFORM SYNTHETIC MESH?

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

What is the FDA product code for POLYFORM SYNTHETIC MESH?

The FDA product code for POLYFORM SYNTHETIC MESH is OTO.

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Other records listing Proxy Biomedical , 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.

K172636VitaMESH Macroporous PP Surgical MeshK111121VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESHK060520VITAMESH MACROPOROUS PP SURGICAL MESHK052100MODIFICATION TO MOTIFMESH SOFT TISSUE PATCHK050678MOTIFMESH SOFT TISSUE PATCH

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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