Self-Cath and Self-Cath Plus— 510(k) K221401
Substantially EquivalentColoplast
FDA 510(k) clearance K221401 for Self-Cath and Self-Cath Plus, Substantially Equivalent on 2022-12-02. Applicant: Coloplast. Device class: 2.
Clearance details
- Applicant
- Coloplast
- Product code
- Code EZD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code EZD
view allMore clearances from Coloplast
view all- K241028 — Luja female (4 models)
- K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
- K230165 — Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
- K223821 — Self-Cath Closed System
- K222059 — SpeediCath Flex Set
Adverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.