510(k) K182998 ยท OCX Endoscopic Irrigation/Suction System
Andorate Auxiliary Water Connector
| Applicant | Smartdata Suzhou Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Apr 17, 2019 |
| Received | Oct 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182998
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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 C Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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: EN10229.2 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED STOPCON Suction Valve-Suction Valve for GI-Endoscope
DISTRIBUTED BY: KEY SURGICAL
8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA
Product Code: EN10232 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve
Product Code: GAR004 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector
Product Code: GAR046 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus
Product Code: GAR3846 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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: 1203-71 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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: 1203-72 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501
Product Code: 345SVVO1 Terminated |
OCX | None listed |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED ScopeValet Guardian Disposable Endoscope Valves Set-
Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector
Product Code: 345SVVO4 Terminated |
OCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.