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FDA 510(k)

HERNIAMESH SURGICAL MESHES

K-Number: K973955 · 1998-05-11

ApplicantHerniamesh
Decision Date1998-05-11
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HERNIAMESH SURGICAL MESHES is the device name listed in this FDA 510(k) record. The listed applicant is Herniamesh. It received FDA 510(k) clearance on 1998-05-11 under 510(k) number K973955. 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 HERNIAMESH SURGICAL MESHES?

HERNIAMESH SURGICAL MESHES is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is Herniamesh. The 510(k) number is K973955.

When did HERNIAMESH SURGICAL MESHES receive FDA 510(k) clearance?

HERNIAMESH SURGICAL MESHES received FDA 510(k) clearance on 1998-05-11, under 510(k) number K973955.

Who is the listed applicant for HERNIAMESH SURGICAL MESHES?

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

What is the FDA product code for HERNIAMESH SURGICAL MESHES?

The FDA product code for HERNIAMESH SURGICAL MESHES is FTL.

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 Herniamesh 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.

K020652HERNIAMESH T-SLING

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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