Self-retaining Retractor

FDA 510(k) K161004 · Fetzer Medical GmbH & Co. KG

Substantially Equivalent

510(k) numberK161004

Submission

Device name
Self-retaining Retractor
Applicant
Fetzer Medical GmbH & Co. KG
Tuttlingen, DE
Received
April 11, 2016
Decision date
September 9, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZT – Retractor, Self-Retaining, For Neurosurgery
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4800
Specialty
Neurology

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K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional Nico Corporation06/12/2015SE
K120691Brain PortGZT · Traditional Nico Corporation06/05/2012SE
K113273Spotlight Access SystemGZT · Traditional Johnson & Johnson01/27/2012SE

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Questions and answers

When was Self-retaining Retractor cleared by the FDA?

Self-retaining Retractor (K161004) received a 510(k) decision of Substantially Equivalent on September 9, 2016, 151 days after the submission was received.

What is the product code of K161004?

The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.