Eigr Surgical Illumination System

FDA 510(k) K113697 · Invuity, Inc.

Substantially Equivalent

510(k) numberK113697

Submission

Device name
Eigr Surgical Illumination System
Applicant
Invuity, Inc.
San Franciso, CA, US
Received
December 16, 2011
Decision date
February 10, 2012
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FST – Light, Surgical, Fiberoptic
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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Questions and answers

When was Eigr Surgical Illumination System cleared by the FDA?

Eigr Surgical Illumination System (K113697) received a 510(k) decision of Substantially Equivalent on February 10, 2012, 56 days after the submission was received.

What is the product code of K113697?

The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.