Disposable Veress Needles

FDA 510(k) K232401 · Hangzhou Kangji Medical Instrument Co., Ltd.

Substantially Equivalent

510(k) numberK232401

Submission

Device name
Disposable Veress Needles
Applicant
Hangzhou Kangji Medical Instrument Co., Ltd.
Hangzhou, CN
Received
August 10, 2023
Decision date
December 14, 2023
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

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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
K232902EVA15 insufflatorHIF · Traditional Palliare , Ltd.05/02/2024SE
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

More from Tautona Group Research & Development, Co., LLC

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K250643Disposable Polymer Ligation ClipsFZP · Traditional 11/20/2025SE
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Questions and answers

When was Disposable Veress Needles cleared by the FDA?

Disposable Veress Needles (K232401) received a 510(k) decision of Substantially Equivalent on December 14, 2023, 126 days after the submission was received.

What is the product code of K232401?

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