FDA 510(k)

EVA 15 Insufflator

K-Number: K193520 · 2020-07-23

Decision Date2020-07-23

Product CodeHIF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

EVA 15 Insufflator is a medical device manufactured by Palliare , Ltd.. It received FDA 510(k) clearance on 2020-07-23 under approval number K193520. 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 EVA 15 Insufflator?

EVA 15 Insufflator is a medical device that received FDA 510(k) clearance on 2020-07-23. It is manufactured by Palliare , Ltd.. The 510(k) number is K193520.

When was EVA 15 Insufflator approved by the FDA?

EVA 15 Insufflator received FDA 510(k) clearance on 2020-07-23, under approval number K193520.

What company makes EVA 15 Insufflator?

EVA 15 Insufflator is manufactured by Palliare , Ltd..

What is the FDA product code for EVA 15 Insufflator?

The FDA product code for EVA 15 Insufflator is HIF.

Other Devices by Palliare , Ltd.

K202799EVA15 K202922END 200 Endoscopic Tubeset K230474EVA5 Insufflator K222901EVA15 insufflator K232902EVA15 insufflator

Related Devices (Code: HIF)

K162648U-Blade Veress NeedleTianjin Uwell Medical Device Manufacturing Co., Ltd. K153367S698 Symbioz flowSopro - Acteon Group K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation KitFisher & Paykel Healthcare K171139LaparoLight Veress NeedleBuffalo Filter, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.