GTK Veress Needles
K-Number: K193339 · 2020-01-30
Decision Date2020-01-30
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
GTK Veress Needles is a medical device manufactured by Guangzhou T.K Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2020-01-30 under approval number K193339. 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 GTK Veress Needles?
GTK Veress Needles is a medical device that received FDA 510(k) clearance on 2020-01-30. It is manufactured by Guangzhou T.K Medical Instrument Co., Ltd.. The 510(k) number is K193339.
When was GTK Veress Needles approved by the FDA?
GTK Veress Needles received FDA 510(k) clearance on 2020-01-30, under approval number K193339.
What company makes GTK Veress Needles?
GTK Veress Needles is manufactured by Guangzhou T.K Medical Instrument Co., Ltd..
What is the FDA product code for GTK Veress Needles?
The FDA product code for GTK Veress Needles 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.