OptiVu Shoulder— 510(k) K250108

Substantially Equivalent

Mr Surgical Solutions, LLC

FDA 510(k) clearance K250108 for OptiVu Shoulder, Substantially Equivalent on 2025-07-09. Applicant: Mr Surgical Solutions, LLC. Device class: 2.

Clearance details

Applicant: Mr Surgical Solutions, LLC
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-01-16
Decision date: 2025-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conshohocken, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Mr Surgical Solutions, LLC

K252530 — OptiVu Shoulder2025-09-10
K252170 — OptiVu Shoulder2025-08-08

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