Endoscopy Irrigation Tubing
FDA 510(k) clearance K230773 · decided 2023-11-21
Clearance details
- K-number
- K230773
- Device name
- Endoscopy Irrigation Tubing
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-21
- Decision date
- 2023-11-21
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| ClearCap Distal Attachment (K242134) | Finemedix Co., Ltd. | 2024-08-20 |
| troCarWash™ System (K233442) | Biotex, Inc. | 2024-05-21 |
| Air/Water Bottle Tubing, CO2 Source Tubing (K231471) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 |
| ENDOGATOR™ Hybrid Irrigation Tubing (K231418) | Medivators | 2023-08-14 |
| Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (K231602) | Ga Health Company Limited | 2023-08-01 |
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Recalls involving this device
No recalls on record reference this clearance.