# Coloplast Manufacturing Us, LLC

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 4 (2007–2010): 4 510(k) clearances
- Product codes: OTM (1), EZD (1), GAW (1), FCM (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 11 (0 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
- Mentor Corp.: 2 (https://510kreport.com/company/mentor)
- American Medical Systems, Inc.: 1 (https://510kreport.com/company/american-medical-systems)

## Firms that cite its devices most
- Coloplast A/S: 3 (https://510kreport.com/company/coloplast-a-s)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Convatec Limited: 2 (https://510kreport.com/company/convatec)
- Dynarex Corp.: 1 (https://510kreport.com/company/dynarex)
- Coloplast Corp.: 1 (https://510kreport.com/company/coloplast)
- Flexicare Medical Limited.: 1 (https://510kreport.com/company/flexicare-medical)
- Compactcath, Inc.: 1 (https://510kreport.com/company/compactcath)

## Its most-cited devices
- K100878: Self Cath Catheter (2010), cited by 8
- K082640: Virtue Ventral Urethral Elevation Sling System (2008), cited by 2
- K093112: Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge (2010), cited by 1

## Recent decisions
- K100878: Self Cath Catheter (May 26, 2010)
- K093112: Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge (Feb 1, 2010)
- K082640: Virtue Ventral Urethral Elevation Sling System (Oct 17, 2008)
- K070939: Self-Cath CS Closed Urinary Catheterization System (Jun 1, 2007)

Source page: https://510kreport.com/company/coloplast-manufacturing-us