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FDA 510(k)

COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH

K-Number: K915526 · 1992-05-29

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1992-05-29
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1992-05-29 under 510(k) number K915526. 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 COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH?

COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH is a medical device that received FDA 510(k) clearance on 1992-05-29. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K915526.

When did COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH receive FDA 510(k) clearance?

COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH received FDA 510(k) clearance on 1992-05-29, under 510(k) number K915526.

Who is the listed applicant for COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH?

The FDA product code for COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL 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

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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