# Uromed Corp.

- Location (FDA's records): Needham, MA
- FDA decisions: 11 (1996–2001): 10 510(k) clearances and 1 original PMA approval
- Product codes: ETN (3), FGM (2), KXK (1), MNG (1), FHA (1), KNA (1), OCW (1), OCK (1)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Acufex Microsurgical, Inc.: 2 (https://510kreport.com/company/acufex-microsurgical)
- 3M Company: 1 (https://510kreport.com/company/3m)
- Ml Strategies, Inc.: 1 (https://510kreport.com/company/ml-strategies)
- North American Scientific, Inc.: 1 (https://510kreport.com/company/north-american-scientific)
- Theragenics Corp.: 1 (https://510kreport.com/company/theragenics)
- Advanced Surgical Intervention, Inc.: 1 (https://510kreport.com/company/advanced-surgical-intervention)
- Nebel, Inc.: 1 (https://510kreport.com/company/nebel)
- Dacomed Corp.: 1 (https://510kreport.com/company/dacomed)

## Firms that cite its devices most
- Bebig Isotopen-Und Medizintechnik GmbH: 2 (https://510kreport.com/company/bebig-isotopen-und-medizintechnik)
- Nebl, Inc.: 1 (https://510kreport.com/company/nebl)
- Bebig Isotopentechnik GmbH: 1 (https://510kreport.com/company/bebig-isotopentechnik)
- Allotrope Medical, Inc.: 1 (https://510kreport.com/company/allotrope-medical)

## Its most-cited devices
- K982226: Uromed Brachytheraphy Iodine-125 Sources (1999), cited by 3
- K974600: Uromed Patch (1998), cited by 1
- K993436: Cavermap Surgical Aid (2000), cited by 1
- K970971: Uro Med Nerve Stimulator (1997), cited by 1

## Recent decisions
- K010213: Modification to Cavermap Surgical Aid (Apr 20, 2001)
- K010098: Modification to Cavermap Surgical Aid (Feb 1, 2001)
- K000507: Cavermap Surgical Aid (Apr 21, 2000)
- K993436: Cavermap Surgical Aid (Feb 11, 2000)
- K982226: Uromed Brachytheraphy Iodine-125 Sources (May 13, 1999)
- K980717: Uromed Sling Kit (May 22, 1998)
- K974600: Uromed Patch (Mar 31, 1998)
- K974137: Uromed Needle Grasper (Jan 30, 1998)

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