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FDA 510(k)

PROLENE (Polypropylene) 3D Patch

K-Number: K181268 · 2018-07-26

ApplicantETHICON, Inc.
Decision Date2018-07-26
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROLENE (Polypropylene) 3D Patch is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2018-07-26 under approval number K181268. 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) 3D Patch?

PROLENE (Polypropylene) 3D Patch is a medical device that received FDA 510(k) clearance on 2018-07-26. It is manufactured by ETHICON, Inc.. The 510(k) number is K181268.

When was PROLENE (Polypropylene) 3D Patch approved by the FDA?

PROLENE (Polypropylene) 3D Patch received FDA 510(k) clearance on 2018-07-26, under approval number K181268.

What company makes PROLENE (Polypropylene) 3D Patch?

PROLENE (Polypropylene) 3D Patch is manufactured by ETHICON, Inc..

What is the FDA product code for PROLENE (Polypropylene) 3D Patch?

The FDA product code for PROLENE (Polypropylene) 3D Patch is FTL.

Other Devices by ETHICON, Inc.

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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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