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FDA 510(k)

PROLENE Soft Polypropylene Mesh

K-Number: K163152 · 2017-03-11

ApplicantETHICON, Inc.
Decision Date2017-03-11
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROLENE Soft Polypropylene Mesh is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2017-03-11 under approval number K163152. 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 Soft Polypropylene Mesh?

PROLENE Soft Polypropylene Mesh is a medical device that received FDA 510(k) clearance on 2017-03-11. It is manufactured by ETHICON, Inc.. The 510(k) number is K163152.

When was PROLENE Soft Polypropylene Mesh approved by the FDA?

PROLENE Soft Polypropylene Mesh received FDA 510(k) clearance on 2017-03-11, under approval number K163152.

What company makes PROLENE Soft Polypropylene Mesh?

PROLENE Soft Polypropylene Mesh is manufactured by ETHICON, Inc..

What is the FDA product code for PROLENE Soft Polypropylene Mesh?

The FDA product code for PROLENE Soft Polypropylene Mesh is FTL.

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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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