Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
FDA 510(k) clearance K250891 · decided 2025-06-06
Clearance details
- K-number
- K250891
- Device name
- Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
- Applicant
- Convatec Limited
- Decision
- Unknown
- Date received
- 2025-03-25
- Decision date
- 2025-06-06
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- FCM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Flintshire, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (K254076) | C.R. Bard, Inc. | 2026-05-29 |
| Self-Cath Closed System (K223821) | Coloplast | 2023-08-02 |
| AMSELF CLOSED CATHETERIZATION SYSTEM (K082831) | Amsino International, Inc. | 2008-10-23 |
| SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (K070939) | Coloplast Manufacturing Us, LLC | 2007-06-01 |
| GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (K070048) | Marian Medical, Inc. | 2007-03-15 |
| AMSURE URETHRAL CATHETERIZATION TRAY (K030712) | Amsino International, Inc. | 2003-05-23 |
| AMSURE FOLEY INSERTION TRAY (K030664) | Amsino International, Inc. | 2003-05-23 |
| THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (K011055) | Go Medical Industries Pty. , Ltd. | 2001-06-06 |
| RUSCH MMG/O'NEIL CATHETER (K010420) | Rusch, Inc. | 2001-05-09 |
| MENTOR SELF-CATH CLOSED SYSTEM (K003873) | Mentor Corp. | 2001-03-29 |
| THE O'NEIL STERILE FIELD URINARY CATHETER KIT (K002803) | Go Medical Industries Pty. , Ltd. | 2000-12-27 |
| SELF CATH SET/SAFETY CATH (K983010) | Rusch Intl. | 1999-02-12 |
Recalls involving this device
No recalls on record reference this clearance.