troCarWash System
Biotex, Inc. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Houston
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 114 Holmes Rd.
- Statement or summary
- Summary
- Product code
- OCX
- Zip code
- 77045
- Applicant
- Biotex, Inc.
- Decision date
- 2024-05-21
- Decision code
- SESE
- Country code
- US
- Device name
- troCarWash System
- Advisory committee
- GU
- Contact
- Wade Munsch
- K number
- K233442
- State
- TX
- Date received
- 2023-10-18
- Review advisory committee
- SU
- Postal code
- 77045
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Endoscopic Irrigation/Suction System
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 3010288205, 3016096097, 3021023752, 1220592, 1650907, 8010047, 2518897, 3012322232, 3007389669, 2243757, 2244478, 2183446, 3010707607, 3010149039, 9611590, 3010230734, 3003637092, 1722746, 3003782610, 3004111573, 3002808148, 3033589330, 9614434, 2246552, 3044707938, 1320894, 9610877, 3008058134, 1221826, 3010612620, 1037905, 3032507796, 3016678045, 3011050570, 1417592, 9610617, 1000121056, 3020712480, 3014749926, 3008720584 +57 more
- FEI number
- 1000162602, 3010288205, 3016096097, 3021023752, 1220592, 3002808273, 3012322232, 3007389669, 2243757, 2183446, 3010707607, 3008185830, 3010149039, 3010230734, 3003637092, 3003782610, 3004111573, 3002808148, 3033589330, 3002808268, 2246552, 3002913962, 3044707938, 3002806920, 3008058134, 1000237915, 1221826, 3010612620, 1037905, 3032507796, 3016678045, 3011050570, 1417592, 1000121056, 3020712480, 3014749926, 3008720584, 3015225571, 3006891611, 3009420598 +57 more