ENDOSCOPE STERILIZATION TRAY— 510(k) K133942

Name: FDA 510(k) clearance K133942
Creator: U.S. Food and Drug Administration
Published: 2014-08-01

Substantially Equivalent

Intuitive Surgical

FDA 510(k) clearance K133942 for ENDOSCOPE STERILIZATION TRAY, Substantially Equivalent on 2014-08-01. Applicant: Intuitive Surgical. Device class: 2.

Clearance details

Applicant: Intuitive Surgical
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2013-12-23
Decision date: 2014-08-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sunnyvale, CA, 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.