EndoRotor Device
FDA 510(k) clearance DEN200016 · decided 2020-12-23
Clearance details
- K-number
- DEN200016
- Device name
- EndoRotor Device
- Applicant
- Interscope, Inc.
- Decision
- Unknown
- Date received
- 2020-03-16
- Decision date
- 2020-12-23
- Days to decision
- 282 days
- Clearance type
- Direct
- Product code
- QNE
- Device class
- 2
- Regulation number
- 876.4330
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Whitinsville, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.