ENDOFLATOR 40, ENDOFLATOR 50
K-Number: K161554 · 2017-03-02
ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2017-03-02
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
ENDOFLATOR 40, ENDOFLATOR 50 is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2017-03-02 under approval number K161554. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ENDOFLATOR 40, ENDOFLATOR 50?
ENDOFLATOR 40, ENDOFLATOR 50 is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K161554.
When was ENDOFLATOR 40, ENDOFLATOR 50 approved by the FDA?
ENDOFLATOR 40, ENDOFLATOR 50 received FDA 510(k) clearance on 2017-03-02, under approval number K161554.
What company makes ENDOFLATOR 40, ENDOFLATOR 50?
ENDOFLATOR 40, ENDOFLATOR 50 is manufactured by KARL STORZ Endoscopy-America, Inc..
What is the FDA product code for ENDOFLATOR 40, ENDOFLATOR 50?
The FDA product code for ENDOFLATOR 40, ENDOFLATOR 50 is HIF.
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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.