2-Way 100% Silicone Cleartract Catheter
Silq Technologies Corporation · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Sunny Isles Beach
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 323 Sunny Isles Blvd.
- Statement or summary
- Summary
- Product code
- EZL
- Zip code
- 33160
- Applicant
- Silq Technologies Corporation
- Decision date
- 2024-01-23
- Decision code
- SESE
- Country code
- US
- Device name
- 2-Way 100% Silicone Cleartract Catheter
- Advisory committee
- GU
- Contact
- D. Verne Sharma
- K number
- K233013
- State
- FL
- Date received
- 2023-09-22
- Review advisory committee
- GU
- Postal code
- 33160
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Retention Type, Balloon
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5130
- Device class
- 2
- Registration number
- 3006787036, 3030446844, 3000268902, 9616088, 3003965134, 3013298431, 3008502431, 8041005, 3007156625, 3003537036, 2029015, 3027301746, 8040412, 3003814961, 1061124, 9611590, 1055236, 1314417, 9616567, 3005609751, 3010580321, 3040153768, 3003477135, 8043983, 3004111573, 9611712, 3014637079, 3011137372, 3010314836, 3004070478, 3016618143, 3001124136, 3022516937, 1921846, 3005515211, 3003903031, 3010131137, 3015142802, 1417592, 3005483737 +80 more
- FEI number
- 3006787036, 3030446844, 3000268902, 3003965134, 3013298431, 3008502431, 3002807036, 1000160458, 3003537036, 3016261803, 3002808507, 3002807917, 3027301746, 3003814961, 1314417, 3005609751, 3010580321, 3003477135, 3004111573, 3014637079, 3010314836, 3000206435, 3001236905, 3004070478, 3016618143, 3001124136, 3003076831, 1000237915, 3022516937, 1921846, 3005515211, 3003903031, 3010131137, 1000521377, 3015142802, 1417592, 3005483737, 3005669815, 3012421607, 1820334 +80 more