Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
FDA 510(k) K143186 · Erbe USA, Inc.
510(k) numberK143186
Submission
- Device name
- Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
- Applicant
- Erbe USA, Inc.
Marietta, GA, US - Received
- November 5, 2014
- Decision date
- December 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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.
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| K251986 | Auxiliary Water Tube MAJ-855OCX · Traditional | Olympus Medical Systems Corporation | 09/26/2025SE |
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| 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 |
|---|---|---|
| K221177 | Erbe's Tubing/Cap SetsOCX · Traditional | 08/11/2022SE |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorOCX · Special | 06/27/2019SE |
| K190469 | ERBEFLO 2 Disposable Tubing SystemOCX · Traditional | 05/23/2019SE |
| K182444 | ERBEFLO Olympus Scope Port ConnectorOCX · Traditional | 11/06/2018SE |
| K162152 | Erbes CO2 Tubing/Cap SetsFEQ · Special | 08/31/2016SE |
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeGEI · Traditional | 10/27/2015SE |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessoriesGEH · Special | 05/04/2015SE |
| K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…FEQ · Traditional | 12/17/2013SE |
| K133180 | Erbe Esu Model Vio DV with AccessoriesGEI · Special | 12/11/2013SE |
| K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesFEQ · Traditional | 03/22/2011SE |
Questions and answers
When was Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector cleared by the FDA?
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector (K143186) received a 510(k) decision of Substantially Equivalent on December 18, 2014, 43 days after the submission was received.
What is the product code of K143186?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.