EVA15 insufflator

FDA 510(k) K232902 · Palliare , Ltd.

Substantially Equivalent

510(k) numberK232902

Submission

Device name
EVA15 insufflator
Applicant
Palliare , Ltd.
Galway, IE
Received
September 18, 2023
Decision date
May 2, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HIF – Insufflator, Laparoscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1730
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HIF

510(k)DeviceApplicantDecision
K260209ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional Karl Storz SE & CO. KG08/19/2026SE
K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)HIF · Traditional Weyo Surgical Technology , Ltd.06/25/2026SE
K252318Insufflator (OPTO-IFL1000)HIF · Traditional Guangdong Optomedic Technologies, Inc.04/16/2026SE
K250388Endoflator +HIF · Traditional Karl Storz SE & CO. KG09/22/2025SE
K242772AirSurgN Insufflator (10030/AirSurgN)HIF · Traditional SmartsurgN, Inc.04/11/2025SE
K243527High Flow Insufflation Unit (UHI-4)HIF · Traditional Olympus Medical Systems Corporation01/13/2025SE
K242536TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional Tautona Group10/15/2024SE
K232464VereSee Optical Veres Needle SystemHIF · Traditional Freyja Healthcare, LLC05/02/2024SE
K233020TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional Tautona Group Research & Development, Co., LLC01/12/2024SE
K232401Disposable Veress NeedlesHIF · Traditional Hangzhou Kangji Medical Instrument Co., Ltd.12/14/2023SE

More from Hangzhou Kangji Medical Instrument Co., Ltd.

510(k)DeviceDecision
K230474EVA5 InsufflatorFCX · Special 03/24/2023SE
K222901EVA15 insufflatorHIF · Traditional 01/27/2023SE
K202922END 200 Endoscopic TubesetFCX · Traditional 07/08/2021SE
K202799EVA15HIF · Special 10/21/2020SE
K193520EVA 15 InsufflatorHIF · Traditional 07/23/2020SE

Questions and answers

When was EVA15 insufflator cleared by the FDA?

EVA15 insufflator (K232902) received a 510(k) decision of Substantially Equivalent on May 2, 2024, 227 days after the submission was received.

What is the product code of K232902?

The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.