Endorate Valve Sets— 510(k) K181509

Clearance details

Applicant

Smartdata Suzhou Co., Ltd.

Product code

Code OCX

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2018-06-08

Decision date

2018-07-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Suzhou, CN

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• Z-0639-2021 — STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0640-2021 — STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0641-2021 — STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0642-2021 — STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0643-2021 — Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0644-2021 — Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0645-2021 — Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0646-2021 — Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0647-2021 — Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0648-2021 — ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103
• Z-0649-2021 — ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4Class II·Terminated·GA HEALTH COMPANY LIMITED·20201103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181509.