# Promepla Sam

- Location (FDA's records): Monaco, MC
- FDA decisions: 5 (2012–2018): 5 510(k) clearances
- Product codes: KNY (3), OCX (1), FAD (1)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Acmi Corporation: 1 (https://510kreport.com/company/acmi)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Smiths Medical Asd, Inc.: 1 (https://510kreport.com/company/smiths-medical-asd)
- Byrne Medical, Inc.: 1 (https://510kreport.com/company/byrne-medical)
- Future Medical Systems, Inc.: 1 (https://510kreport.com/company/future-medical-systems)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Firms that cite its devices most
- Rocamed Sam: 1 (https://510kreport.com/company/rocamed-sam)

## Its most-cited devices
- K120160: Rocamed Rocaus Platinum (2012), cited by 1
- K173734: RocaJJ Soft Stents (2018), cited by 1
- K140441: BI-Flex Ureteral Access Sheath (2014), cited by 1

## Recent decisions
- K182144: Bi-Flex Evo (Sep 7, 2018)
- K173734: RocaJJ Soft Stents (Mar 12, 2018)
- K152278: ENDOFLOW II - Irrigation, Warming and Suction System (Feb 9, 2016)
- K140441: BI-Flex Ureteral Access Sheath (Jun 17, 2014)
- K120160: Rocamed Rocaus Platinum (May 14, 2012)

Source page: https://510kreport.com/company/promepla-sam