Boa Endoscopic Valve
FDA 510(k) K152140 · C2 Therapeutics, Inc.
510(k) numberK152140
Submission
- Device name
- Boa Endoscopic Valve
- Applicant
- C2 Therapeutics, Inc.
Redwood, Ca, CA, US - Received
- August 3, 2015
- Decision date
- October 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCX – Endoscopic Irrigation/Suction System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
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| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
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| K233442 | troCarWash SystemOCX · Traditional | Biotex, Inc. | 05/21/2024SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/08/2023SE |
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| K161202 | C2 Cryoballoon Ablation SystemGEH · Traditional | 01/05/2017SE |
| K160994 | C2 CryoBalloon Focal Pear CatheterGEH · Special | 05/19/2016SE |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemGEH · Traditional | 04/13/2016SE |
| K153541 | Coldplay CryoBalloon® Ablation SystemGEH · Special | 01/07/2016SE |
| K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemGEH · Special | 07/07/2015SE |
| K150083 | Sidecar External Working ChannelFED · Traditional | 04/14/2015SE |
| K131523 | Cryoballoon Focal Ablation SystemGEH · Special | 08/22/2013SE |
| K101825 | Cryoballoon Ablation SystemGEH · Traditional | 09/29/2010SE |
Questions and answers
When was Boa Endoscopic Valve cleared by the FDA?
Boa Endoscopic Valve (K152140) received a 510(k) decision of Substantially Equivalent on October 13, 2015, 71 days after the submission was received.
What is the product code of K152140?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.