FDA 510(k)

Vesair Cystoscopic Sheath

K-Number: K162356 · 2017-03-02

Decision Date2017-03-02

Product CodeKNY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Vesair Cystoscopic Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Solace Therapeutics. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K162356. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vesair Cystoscopic Sheath?

Vesair Cystoscopic Sheath is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Solace Therapeutics. The 510(k) number is K162356.

When did Vesair Cystoscopic Sheath receive FDA 510(k) clearance?

Vesair Cystoscopic Sheath received FDA 510(k) clearance on 2017-03-02, under 510(k) number K162356.

Who is the listed applicant for Vesair Cystoscopic Sheath?

The FDA 510(k) record lists Solace Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vesair Cystoscopic Sheath?

The FDA product code for Vesair Cystoscopic Sheath is KNY.

Other records listing Solace Therapeutics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope

Related Devices (Code: KNY)

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla Sam

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.