# Pluromed, Inc.

- Location (FDA's records): Woburn, MA
- FDA decisions: 4 (2009–2011): 4 510(k) clearances
- Product codes: KOD (3), ONJ (1)
- Predicates its devices cite: 7 (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
- Boston Scientific Corp: 4 (https://510kreport.com/company/boston-scientific)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)

## Firms that cite its devices most
- Urogen Pharma, Ltd.: 1 (https://510kreport.com/company/urogen-pharma)

## Its most-cited devices
- K103349: Backstop Catheter (2011), cited by 1
- K110491: Backstop Catheter (2011), cited by 1
- K090270: Backstop Catheter, Model 60-0000-3100 (2009), cited by 1

## Recent decisions
- K110491: Backstop Catheter (Mar 16, 2011)
- K103349: Backstop Catheter (Jan 7, 2011)
- K090430: Backstop and Backstop Injector (Jun 2, 2009)
- K090270: Backstop Catheter, Model 60-0000-3100 (May 15, 2009)

Source page: https://510kreport.com/company/pluromed