Endorate Valve Sets
FDA 510(k) clearance K181509 · decided 2018-07-06
Clearance details
- K-number
- K181509
- Device name
- Endorate Valve Sets
- Applicant
- Smartdata Suzhou Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-08
- Decision date
- 2018-07-06
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Suzhou, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.