EIGR SURGICAL ILLUMINATION SYSTEM— 510(k) K113697

Name: FDA 510(k) clearance K113697
Creator: U.S. Food and Drug Administration
Published: 2012-02-10

Substantially Equivalent

Invuity, Inc.

FDA 510(k) clearance K113697 for EIGR SURGICAL ILLUMINATION SYSTEM, Substantially Equivalent on 2012-02-10. Applicant: Invuity, Inc.. Device class: 2.

Clearance details

Applicant: Invuity, Inc.
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2011-12-16
Decision date: 2012-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Franciso, 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.