Vesair Cystoscopic Sheath— 510(k) K162356

Substantially Equivalent

Solace Therapeutics

FDA 510(k) clearance K162356 for Vesair Cystoscopic Sheath, Substantially Equivalent on 2017-03-02. Applicant: Solace Therapeutics. Device class: 2.

Clearance details

Applicant: Solace Therapeutics
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2016-08-23
Decision date: 2017-03-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Farmingham, MA, US

Download summary PDF View on FDA.gov ↗

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