Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
FDA 510(k) clearance K170862 · decided 2017-12-19
Clearance details
- K-number
- K170862
- Device name
- Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
- Applicant
- Solace Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-03-23
- Decision date
- 2017-12-19
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- FAJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Farmingham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.