OpClear System— 510(k) K171637

Substantially Equivalent

Cipher Surgical, Ltd.

FDA 510(k) clearance K171637 for OpClear System, Substantially Equivalent on 2018-02-26. Applicant: Cipher Surgical, Ltd.. Device class: 2.

Clearance details

Applicant: Cipher Surgical, Ltd.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-02
Decision date: 2018-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coventry, GB

Download summary PDF View on FDA.gov ↗

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