Submission Details
| 510(k) Number | K181268 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 14, 2018 |
| Decision Date | July 26, 2018 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
PROLENE (Polypropylene) 3D Patch
Jul 2018
Decision
73d
Days
Class 2
Risk
About This 510(k) Submission
K181268 is an FDA 510(k) clearance for the PROLENE (Polypropylene) 3D Patch, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on July 26, 2018, 73 days after receiving the submission on May 14, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
Device Classification
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
Manufacturer
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