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FDA 510(k)

PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH

K-Number: K962530 · 1996-08-09

ApplicantETHICON, Inc.
Decision Date1996-08-09
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1996-08-09 under 510(k) number K962530. 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 PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH?

PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH is a medical device that received FDA 510(k) clearance on 1996-08-09. The listed applicant is ETHICON, Inc.. The 510(k) number is K962530.

When did PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH receive FDA 510(k) clearance?

PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH received FDA 510(k) clearance on 1996-08-09, under 510(k) number K962530.

Who is the listed applicant for PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH?

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

What is the FDA product code for PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH?

The FDA product code for PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH is FTL.

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Other records listing ETHICON, Inc. as applicant

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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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