Vacutore Air/Water Bottle Tubing

Q: What is the product code of K191366?

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) K191366 · Smartdata Suzhou Co., Ltd.

Substantially Equivalent

510(k) numberK191366

Submission

Device name: Vacutore Air/Water Bottle Tubing
Applicant: Smartdata Suzhou Co., Ltd.
Suzhou, CN
Received: May 22, 2019
Decision date: September 6, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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

510(k)	Device	Applicant	Decision
K251986	Auxiliary Water Tube MAJ-855OCX · Traditional	Olympus Medical Systems Corporation	09/26/2025SE
K251997	Single-Use Biopsy Valve (MAJ-1555)OCX · Traditional	Olympus Medical Systems Corporation	09/25/2025SE
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

More from Zhejiang Chuangxiang Medical Technology Co., Ltd.

510(k)	Device	Decision
K191231	Andorate Auxiliary Water Connector, Andorate Valves SetODC · Traditional	06/07/2019SE
K182998	Andorate Auxiliary Water ConnectorOCX · Traditional	04/17/2019SE
K181509	Endorate Valve SetsOCX · Traditional	07/06/2018SE

Questions and answers

When was Vacutore Air/Water Bottle Tubing cleared by the FDA?

Vacutore Air/Water Bottle Tubing (K191366) received a 510(k) decision of Substantially Equivalent on September 6, 2019, 107 days after the submission was received.

What is the product code of K191366?

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