ViSiGi 3D Gastric Sizing Tube
Boehringer Laboratories · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Phoenixville
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 300 Thoms Dr.
- Statement or summary
- Summary
- Product code
- KNT
- Zip code
- 19460
- Applicant
- Boehringer Laboratories
- Decision date
- 2024-01-26
- Decision code
- SESE
- Country code
- US
- Device name
- ViSiGi 3D Gastric Sizing Tube
- Advisory committee
- GU
- Contact
- Nathan Simasek
- K number
- K234145
- State
- PA
- Date received
- 2023-12-29
- Review advisory committee
- GU
- Postal code
- 19460
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Tubes, Gastrointestinal (And Accessories)
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5980
- Device class
- 2
- Registration number
- 1214422, 3025772870, 3030446844, 3000268902, 9616088, 3006538822, 3018094310, 3013298431, 1313046, 3008044552, 3004122598, 9617594, 1223925, 3006673317, 3014421917, 2029015, 3014663754, 3013234390, 1055236, 9611590, 1314417, 3007285848, 3031289255, 3013524793, 1221485, 3005609751, 2183673, 1526012, 3017081712, 3004111573, 3014656668, 3014637079, 3011137372, 3043226252, 3010757606, 3044994889, 1221765, 3006271008, 3006017180, 3006157842 +193 more
- FEI number
- 1214422, 3025772870, 3030446844, 3000268902, 3018094310, 3006538822, 1313046, 3013298431, 3008044552, 3004122598, 3002806565, 1000160458, 3014421917, 1000283452, 3002808127, 3014663754, 3013234390, 1000120555, 1314417, 3007285848, 3031289255, 3013524793, 1221485, 3005609751, 2183673, 3932, 3003015552, 1526012, 3017081712, 3004111573, 3014656668, 3014637079, 3043226252, 3000206435, 3010757606, 3044994889, 1221765, 3001236905, 3006017180, 3006271008 +192 more