ENDOFLOW II - Irrigation, Warming and Suction System

Q: What is the product code of K152278?

The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.

FDA 510(k) K152278 · Promepla Sam

Substantially Equivalent

510(k) numberK152278

Submission

Device name: ENDOFLOW II - Irrigation, Warming and Suction System
Applicant: Promepla Sam
Monaco, MC
Received: August 12, 2015
Decision date: February 9, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OCX – Endoscopic Irrigation/Suction System
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.1500
Specialty: Gastroenterology, Urology

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

Other 510(k)s with product code OCX

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K242586	ArgoCap (200.52)OCX · Traditional	Ovesco Endoscopy AG	05/22/2025SE
K241704	Endoscopic Water PumpOCX · Traditional	Hangzhou AGS MedTech Co., Ltd.	03/20/2025SE
K242357	Water Container (MAJ-901); Water Container (MAJ-902)OCX · Traditional	Olympus Medical Systems Corporation	10/07/2024SE
K241874	Aspiration Catheter (2189)OCX · Traditional	Hobbs Medical, Inc.	09/24/2024SE
K242134	ClearCap Distal AttachmentOCX · Special	Finemedix Co., Ltd.	08/20/2024SE
K233442	troCarWash SystemOCX · Traditional	Biotex, Inc.	05/21/2024SE
K230773	Endoscopy Irrigation TubingOCX · Traditional	Zhejiang Chuangxiang Medical Technology Co., Ltd.	11/21/2023SE
K231471	Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional	Zhejiang Chuangxiang Medical Technology Co., Ltd.	09/08/2023SE

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Questions and answers

When was ENDOFLOW II - Irrigation, Warming and Suction System cleared by the FDA?

ENDOFLOW II - Irrigation, Warming and Suction System (K152278) received a 510(k) decision of Substantially Equivalent on February 9, 2016, 181 days after the submission was received.

What is the product code of K152278?

The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.