CVAC® Aspiration System
Calyxo, Inc. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Pleasanton
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 4473 Willow Rd., Suite 100
- Statement or summary
- Summary
- Product code
- FGB
- Zip code
- 94588
- Applicant
- Calyxo, Inc.
- Decision date
- 2026-09-15
- Decision code
- SESE
- Country code
- US
- Device name
- CVAC® Aspiration System
- Advisory committee
- GU
- Contact
- Joseph Catanese III
- K number
- K261447
- State
- CA
- Date received
- 2026-05-01
- Review advisory committee
- GU
- Postal code
- 94588
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Ureteroscope And Accessories, Flexible/Rigid
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 3017425975, 8043903, 3014683069, 3013992977, 3013247477, 3017210488, 3005580113, 3011986317, 3032959393, 3014893827, 3010220595, 1000121056, 3012797688, 9616693, 3021246306, 3004040397, 3004111573, 3014644276, 1418479, 1820334, 3010421104, 3021031769, 3025349506, 3032429484, 3022106566, 3012322232, 3020746799, 3037966040, 2936485, 3004361445, 2531475, 3017367014, 3012843412, 3015139943, 3003206812, 9610773, 3008776287, 3042940358, 3002808148, 9610595 +81 more
- FEI number
- 3014683069, 3013992977, 3002808273, 3013247477, 3017210488, 3005580113, 3003922255, 3011986317, 3032959393, 3014893827, 3010220595, 1000121056, 3012797688, 3021246306, 3008185830, 3004040397, 3004111573, 1418479, 1820334, 3010421104, 3021031769, 3025349506, 3032429484, 3022106566, 3012322232, 3020746799, 3037966040, 2936485, 3004361445, 3017367014, 3006149253, 3015139943, 3012843412, 3003206812, 3006759904, 3008776287, 3002808268, 3007475226, 3002806565, 3002808148 +81 more