Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope— 510(k) K170862

Substantially Equivalent

Solace Therapeutics, Inc.

FDA 510(k) clearance K170862 for Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope, Substantially Equivalent on 2017-12-19. Applicant: Solace Therapeutics, Inc..

Clearance details

Applicant: Solace Therapeutics, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2017-03-23
Decision date: 2017-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingham, MA, US

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Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.