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FDA 510(k)

Air/Water Bottle Tubing, CO2 Source Tubing

K-Number: K231471 · 2023-09-08

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2023-09-08
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Air/Water Bottle Tubing, CO2 Source Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231471. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Air/Water Bottle Tubing, CO2 Source Tubing?

Air/Water Bottle Tubing, CO2 Source Tubing is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K231471.

When did Air/Water Bottle Tubing, CO2 Source Tubing receive FDA 510(k) clearance?

Air/Water Bottle Tubing, CO2 Source Tubing received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231471.

Who is the listed applicant for Air/Water Bottle Tubing, CO2 Source Tubing?

The FDA 510(k) record lists Zhejiang Chuangxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air/Water Bottle Tubing, CO2 Source Tubing?

The FDA product code for Air/Water Bottle Tubing, CO2 Source Tubing is OCX.

Other records listing Zhejiang Chuangxiang Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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