VereSee Optical Veres Needle System

Q: What is the product code of K232464?

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

FDA 510(k) K232464 · Freyja Healthcare, LLC

Substantially Equivalent

510(k) numberK232464

Submission

Device name: VereSee Optical Veres Needle System
Applicant: Freyja Healthcare, LLC
North Andover, MA, US
Received: August 15, 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)	Device	Applicant	Decision
K260209	ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional	Karl Storz SE & CO. KG	08/19/2026SE
K252584	Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)HIF · Traditional	Weyo Surgical Technology , Ltd.	06/25/2026SE
K252318	Insufflator (OPTO-IFL1000)HIF · Traditional	Guangdong Optomedic Technologies, Inc.	04/16/2026SE
K250388	Endoflator +HIF · Traditional	Karl Storz SE & CO. KG	09/22/2025SE
K242772	AirSurgN Insufflator (10030/AirSurgN)HIF · Traditional	SmartsurgN, Inc.	04/11/2025SE
K243527	High Flow Insufflation Unit (UHI-4)HIF · Traditional	Olympus Medical Systems Corporation	01/13/2025SE
K242536	TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional	Tautona Group	10/15/2024SE
K232902	EVA15 insufflatorHIF · Traditional	Palliare , Ltd.	05/02/2024SE
K233020	TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional	Tautona Group Research & Development, Co., LLC	01/12/2024SE
K232401	Disposable Veress NeedlesHIF · Traditional	Hangzhou Kangji Medical Instrument Co., Ltd.	12/14/2023SE

More from Hangzhou Kangji Medical Instrument Co., Ltd.

510(k)	Device	Decision
K261139	VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional	08/13/2026SE
K252640	VereSee Optical Veres Needle and Endoscopic CameraGCJ · Traditional	10/20/2025SE

Questions and answers

When was VereSee Optical Veres Needle System cleared by the FDA?

VereSee Optical Veres Needle System (K232464) received a 510(k) decision of Substantially Equivalent on May 2, 2024, 261 days after the submission was received.

What is the product code of K232464?

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