Invuity Britefield Mcculloch Retractor System

FDA 510(k) K090070 · Invuity, Inc.

Substantially Equivalent

510(k) numberK090070

Submission

Device name
Invuity Britefield Mcculloch Retractor System
Applicant
Invuity, Inc.
Sunnyvale, CA, US
Received
January 12, 2009
Decision date
April 22, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Invuity Britefield Mcculloch Retractor System cleared by the FDA?

Invuity Britefield Mcculloch Retractor System (K090070) received a 510(k) decision of Substantially Equivalent on April 22, 2009, 100 days after the submission was received.

What is the product code of K090070?

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