Boa Endoscopic Valve
510(k) K152140
Boa Endoscopic Valve is a medical device (FDA Class II; FDA product code OCX, Endoscopic Irrigation/Suction System) made by C2 Therapeutics, Inc., cleared under FDA 510(k) K152140 on 13 Oct 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152140 | Date13 Oct 2015 | StatusActive |
Official records
- FDA 510(k) database K152140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OCX
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K152140
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BOA Endoscopic Valve FG-1016 | FG-1016 / FG-1016 | 00854924006163 | — | On the market |
Similar devices
Other devices filed under FDA product code OCX (Endoscopic Irrigation/Suction System).
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- ENDOGATOR™ Hybrid Irrigation Tubing by MEDIVATORS INC.
- Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing by Diversatek Healthcare
- ENDOGATOR 100116 by MEDIVATORS INC.
- Irrigation Tubing with CO2 or Air by KeyMed (Medical and Industrial Equipment) Ltd
- BioShield 00711137 by US Endoscopy