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FDA 510(k)

APA Oxy Blade

K-Number: K191602 · 2019-08-02

ApplicantVenner Medical (Singapore) Pte, Ltd.
Decision Date2019-08-02
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APA Oxy Blade is a medical device manufactured by Venner Medical (Singapore) Pte, Ltd.. It received FDA 510(k) clearance on 2019-08-02 under approval number K191602. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APA Oxy Blade?

APA Oxy Blade is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Venner Medical (Singapore) Pte, Ltd.. The 510(k) number is K191602.

When was APA Oxy Blade approved by the FDA?

APA Oxy Blade received FDA 510(k) clearance on 2019-08-02, under approval number K191602.

What company makes APA Oxy Blade?

APA Oxy Blade is manufactured by Venner Medical (Singapore) Pte, Ltd..

What is the FDA product code for APA Oxy Blade?

The FDA product code for APA Oxy Blade is CCW.

Other Devices by Venner Medical (Singapore) Pte, Ltd.

K192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm K192120Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm

Related Devices (Code: CCW)

K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLC

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.

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