Self-retaining Retractor
K-Number: K161004 · 2016-09-09
ApplicantFetzer Medical GmbH & Co. KG
Decision Date2016-09-09
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Self-retaining Retractor is a medical device manufactured by Fetzer Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2016-09-09 under approval number K161004. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Self-retaining Retractor?
Self-retaining Retractor is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Fetzer Medical GmbH & Co. KG. The 510(k) number is K161004.
When was Self-retaining Retractor approved by the FDA?
Self-retaining Retractor received FDA 510(k) clearance on 2016-09-09, under approval number K161004.
What company makes Self-retaining Retractor?
Self-retaining Retractor is manufactured by Fetzer Medical GmbH & Co. KG.
What is the FDA product code for Self-retaining Retractor?
The FDA product code for Self-retaining Retractor is GZT.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.