Company ยท MC
Promepla Sam
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2018. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 2018 | K182144 | Bi-Flex Evo Promepla Sam, MC | KNY |
| Mar 12, 2018 | K173734 | RocaJJ Soft Stents Promepla Sam, MC | FAD |
| Feb 9, 2016 | K152278 | ENDOFLOW II - Irrigation, Warming and Suction System Promepla Sam, MC | OCX |
| Jun 17, 2014 | K140441 | BI-FLEX URETERAL ACCESS SHEATH Promepla Sam, MC | KNY |
| May 14, 2012 | K120160 | ROCAMED ROCAUS PLATINUM Promepla Sam, MC | KNY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||