Transurethral Catheter Safety Valve (TUCSV) (80050)
Class Medical , Ltd. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Co Limerick
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- Unit 1d Annacotty Business Park
- Address 2
- Annacotty
- Statement or summary
- Summary
- Product code
- KNY
- Applicant
- Class Medical , Ltd.
- Decision date
- 2026-08-05
- Decision code
- SESE
- Country code
- IE
- Device name
- Transurethral Catheter Safety Valve (TUCSV) (80050)
- Advisory committee
- GU
- Contact
- Danny Forde
- K number
- K260919
- Date received
- 2026-03-19
- Review advisory committee
- GU
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Accessories, Catheter, G-U
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5130
- Device class
- 2
- Registration number
- 3010202439, 1018233, 3005232773, 2032112, 9612030, 3014342096, 3006082230, 3011050570, 2029275, 3004111573, 3002807314, 9680787, 3016171914, 2126666, 9610617, 1220477, 2029015, 3006174295, 1625425, 1423537, 3003915875, 3009051888, 2183744, 3003790304, 3012322232, 9681477, 3010707607, 3041276591, 2027111, 2032098, 3016096097, 1921846, 9611590, 3010155661, 3009763019, 2022435, 9617594, 1713468, 2020550, 8010418
- FEI number
- 1018233, 1000306431, 3005232773, 3014342096, 3006082230, 3011050570, 3004111573, 3002807314, 3016171914, 2126666, 3003058448, 1220477, 3003807466, 3006174295, 3007130719, 1625425, 3003076831, 3009051888, 3003915875, 2183744, 3003790304, 3012322232, 3010707607, 3002826093, 3002806934, 3041276591, 2027111, 1000160458, 3002807439, 3016096097, 1921846, 3002808268, 3010155661, 3009763019, 1000237915, 3007475226, 2022435, 1713468, 3001236905, 2020550