Submission Details
| 510(k) Number | K180910 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 2018 |
| Decision Date | July 02, 2018 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
ULTRAPRO Mesh and ULTRAPRO ADVANCED
Jul 2018
Decision
87d
Days
Class 2
Risk
About This 510(k) Submission
K180910 is an FDA 510(k) clearance for the ULTRAPRO Mesh and ULTRAPRO ADVANCED, 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 2, 2018, 87 days after receiving the submission on April 6, 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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