EndoClot
FDA 510(k) clearance K190677 · decided 2021-01-29
Clearance details
- K-number
- K190677
- Device name
- EndoClot
- Applicant
- Endoclot Plus Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-03-15
- Decision date
- 2021-01-29
- Days to decision
- 686 days
- Clearance type
- Traditional
- Product code
- QAU
- Device class
- 2
- Regulation number
- 878.4456
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.