Promepla S.A.M
MONACO Monaco-Ville, MC
PROMEPLA S.A.M appears in FDA device records in MONACO Monaco-Ville, MC. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Promepla S.A.M between 2012 and 2018. The busiest year on record is 2018, with 2. The most recent is 2018, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182144 | Bi-Flex Evo | KNY | Substantially Equivalent | |
| K173734 | RocaJJ Soft Stents | FAD | Substantially Equivalent | |
| K152278 | ENDOFLOW II - Irrigation, Warming and Suction System | OCX | Substantially Equivalent | |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | KNY | Substantially Equivalent | |
| K120160 | ROCAMED ROCAUS PLATINUM | KNY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006617533 | 3006617533 | PROMEPLA S.A.M | 9 AVENUE PRINCE ALBERT II, MONACO Monaco-Ville 98000 MC | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNYAccessories, Catheter, G-U
- GBXCatheter, Irrigation
- FENDevice, Cystometric, Hydraulic
- FGODislodger, Stone, Flexible
- OCXEndoscopic Irrigation/Suction System
- IZQInjector, Contrast Medium, Automatic
- FFKLithotriptor, Electro-Hydraulic
- FEOLithotriptor, Ultrasonic
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt
- GCBNeedle, Catheter
- BTAPump, Portable, Aspiration (Manual Or Powered)
- FADStent, Ureteral
- BYYTube, Aspirating, Flexible, Connecting
- FCZTube, Smoke Removal, Endoscopic
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain