ClearCap Distal Attachment
FDA 510(k) clearance K202616 · decided 2021-02-19
Clearance details
- K-number
- K202616
- Device name
- ClearCap Distal Attachment
- Applicant
- Finemedix Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-09
- Decision date
- 2021-02-19
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Daegu, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.