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FDA 510(k)

HYDROCOAT MESH

K-Number: K090271 · 2010-01-14

ApplicantPromethean Surgical Devices, Inc.
Decision Date2010-01-14
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDROCOAT MESH is the device name listed in this FDA 510(k) record. The listed applicant is Promethean Surgical Devices, Inc.. It received FDA 510(k) clearance on 2010-01-14 under 510(k) number K090271. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROCOAT MESH?

HYDROCOAT MESH is a medical device that received FDA 510(k) clearance on 2010-01-14. The listed applicant is Promethean Surgical Devices, Inc.. The 510(k) number is K090271.

When did HYDROCOAT MESH receive FDA 510(k) clearance?

HYDROCOAT MESH received FDA 510(k) clearance on 2010-01-14, under 510(k) number K090271.

Who is the listed applicant for HYDROCOAT MESH?

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

What is the FDA product code for HYDROCOAT MESH?

The FDA product code for HYDROCOAT MESH is FTL.

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Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

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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