# Uroplasty, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 9 (2005–2012): 8 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Uroplasty, Inc. (8); Uroplasty, LLC (1)
- Product codes: NAM (4), FBK (3), LNM (1), OTN (1)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 9 (5 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
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)
- Advanced Uroscience, Inc.: 1 (https://510kreport.com/company/advanced-uroscience)

## Firms that cite its devices most
- Neomedic International S.L.: 1 (https://510kreport.com/company/neomedic-international)
- Advanced Uro-Solutions, Inc.: 1 (https://510kreport.com/company/advanced-uro-solutions)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- Exodus Innovations: 1 (https://510kreport.com/company/exodus-innovations)

## Its most-cited devices
- K051905: Uroplasty Rigid Endoscopic Needle (2005), cited by 2
- K071822: Urgent PC Neuromodulation System, Models UPC200 and UPC250-12 (2007), cited by 2
- K061333: Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 (2006), cited by 1
- K052175: I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000 (2005), cited by 1
- K091391: Uroplasty Rigid Endoscopic Needle, MRN-518 (2009), cited by 1
- K101847: Urgent PC Stimulator; Urgent PC Lead Set (2010), cited by 1

## Recent decisions
- K121337: Uroplasty Rigid Endoscpic Needles (Aug 3, 2012)
- K101847: Urgent PC Stimulator; Urgent PC Lead Set (Oct 21, 2010)
- K091391: Uroplasty Rigid Endoscopic Needle, MRN-518 (Jun 30, 2009)
- K071822: Urgent PC Neuromodulation System, Models UPC200 and UPC250-12 (Aug 20, 2007)
- P040050: Macroplastique Implants (Oct 30, 2006)
- K061333: Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 (Jul 3, 2006)
- K052175: I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000 (Oct 17, 2005)
- K052025: Urgent PC Neuromodulation System (Oct 17, 2005)

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