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FDA 510(k)

FLUOROTEX II SURGICAL MESH

K-Number: K002351 · 2000-08-26

ApplicantBridger Biomed, Inc.
Decision Date2000-08-26
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLUOROTEX II SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Bridger Biomed, Inc.. It received FDA 510(k) clearance on 2000-08-26 under 510(k) number K002351. 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 FLUOROTEX II SURGICAL MESH?

FLUOROTEX II SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2000-08-26. The listed applicant is Bridger Biomed, Inc.. The 510(k) number is K002351.

When did FLUOROTEX II SURGICAL MESH receive FDA 510(k) clearance?

FLUOROTEX II SURGICAL MESH received FDA 510(k) clearance on 2000-08-26, under 510(k) number K002351.

Who is the listed applicant for FLUOROTEX II SURGICAL MESH?

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

What is the FDA product code for FLUOROTEX II SURGICAL MESH?

The FDA product code for FLUOROTEX II SURGICAL MESH is FTL.

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Other records listing Bridger Biomed, Inc. 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.

K003906MODIFICATION TO FLUROTEX SURGICAL MESHK003917MODIFICATION TO FLUOROTEX II SURGICAL MESHK994032FLUORO-TEX CARDIOVASCULAR PATCHK984197FLUOROTEX SURGICAL MESHK980548DURA-PATCH MODEL DP-XXXK973178FLUORO-TEX SURGICAL MEMBRANE

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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