# Coloplast A/S

- Location (FDA's records): Plymouth, MN
- FDA decisions: 71 (1983–2023): 71 510(k) clearances
- Product codes: EXB (11), FRO (6), KMF (5), KNX (5), KNT (4), OTM (4), FED (4), OTO (3), GBM (3), OCY (2), EXJ (2), EXD (2)
- Predicates its devices cite: 48 (19 its own); citations of its devices by later devices: 43 (19 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mpathy Medical Devices, Ltd.: 4 (https://510kreport.com/company/mpathy-medical-devices)
- Coloplast Corp.: 4 (https://510kreport.com/company/coloplast)
- Coloplast Manufacturing Us, LLC: 3 (https://510kreport.com/company/coloplast-manufacturing-us)
- Mentor Corp.: 3 (https://510kreport.com/company/mentor)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Genzyme Surgical Product (Genzyme Biosurgery): 2 (https://510kreport.com/company/genzyme-surgical-product-genzyme-biosurgery)
- Applied Medical Resources: 2 (https://510kreport.com/company/applied-medical-resources)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Coloplast Corp.: 10 (https://510kreport.com/company/coloplast)
- Dentsply Sirona: 2 (https://510kreport.com/company/dentsply-sirona)
- Winner Medical Co., Ltd.: 2 (https://510kreport.com/company/winner-medical)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Well Lead Medical Co., Ltd.: 1 (https://510kreport.com/company/well-lead-medical)
- Convatec Limited: 1 (https://510kreport.com/company/convatec)
- Laboratoires Urgo: 1 (https://510kreport.com/company/laboratoires-urgo)

## Its most-cited devices
- K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM (2010), cited by 5
- K112322: Restorelle Polypropylene Y Mesh (2012), cited by 3
- K121458: Speedicath Compact Set (12/18 FR) (2012), cited by 2
- K083770: Coloplast Peristeen Anal Irrigation (Pai) System (2009), cited by 2
- K140310: Peristeen Anal Irrigation System (2015), cited by 2
- K102485: RE-Trace Ureteral Access Sheath (2010), cited by 2

## Recent decisions
- K221874: Altis Single Incision Sling System (Feb 15, 2023)
- K220420: Saffron Fixation System (Jun 10, 2022)
- K191536: Biatain Silicone Ag (Feb 21, 2020)
- K181811: ReTrace Ureteral Access Sheath (Sep 7, 2018)
- K173527: Digitex Delivery Device (Feb 12, 2018)
- K140310: Peristeen Anal Irrigation System (Sep 3, 2015)
- K150935: SpeediCath Compact Eve (Jul 2, 2015)
- K150927: Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff (May 27, 2015)

Source page: https://510kreport.com/company/coloplast-a-s