Luja Set
510(k) K250270
Luja Set is a Class II device made by Coloplast Corp., cleared under FDA 510(k) K250270 on 17 Apr 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250270 | Date17 Apr 2025 | StatusActive |
Official records
- FDA 510(k) database K250270
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EZD
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K250270
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Luja Set 20071 | 20071 / 20071 | 05708932780766 | Catheter Working Length 13 in; Catheter Working Length 33 cm; Catheter Gauge 10 Fr | On the market |
| Luja Set 20072 | 20072 / 20072 | 05708932780797 | Catheter Gauge 12 Fr; Catheter Working Length 13 in; Catheter Working Length 33 cm | On the market |
| Luja Set 20074 | 20074 / 20074 | 05708932780827 | Catheter Gauge 14 Fr; Catheter Working Length 33 cm; Catheter Working Length 13 in | On the market |
| Luja Set 20076 | 20076 / 20076 | 05708932780858 | Catheter Gauge 16 Fr; Catheter Working Length 13 in; Catheter Working Length 33 cm | On the market |
| Luja Set 20081 | 20081 / 20081 | 05708932783293 | Catheter Working Length 13 in; Catheter Gauge 10 Fr; Catheter Working Length 33 cm | On the market |
| Luja Set 20082 | 20082 / 20082 | 05708932783323 | Catheter Working Length 13 in; Catheter Working Length 33 cm; Catheter Gauge 12 Fr | On the market |
| Luja Set 20084 | 20084 / 20084 | 05708932783354 | Catheter Gauge 14 Fr; Catheter Working Length 13 in; Catheter Working Length 33 cm | On the market |
| Luja Set 20086 | 20086 / 20086 | 05708932783385 | Catheter Working Length 33 cm; Catheter Working Length 13 in; Catheter Gauge 16 Fr | On the market |
Similar devices
Other devices filed under FDA product code EZD (Catheter, Straight).
- DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC by Dynarex Corp.
- COMFORTGLIDE INTERMITENT CATHETER by C. R. Bard, Inc.
- KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER by Kendall Healthcare Products Co. Div.Of Tyco Health
- AMSure® PVC Intermittent Catheter 1 AS861616 by AMSINO INTERNATIONAL, INC.
- PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C by ADAPTA MEDICAL INC
- Coude Sleeved IC; Coude Plus Sleeved IC by Hollister Incorporated
- AMSure® PVC Intermittent Catheter 1 AS861612 by AMSINO INTERNATIONAL, INC.
- CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED by Cure Medical, LLC
- BARD RITECATH INTERMITTENT CATHETER by C. R. Bard, Inc.
- Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) by Hollister Incorporated