Erbeflo 2 Disposable Tubing System
FDA 510(k) K103235 · Erbe USA, Inc.
510(k) numberK103235
Submission
- Device name
- Erbeflo 2 Disposable Tubing System
- Applicant
- Erbe USA, Inc.
Marietta, GA, US - Received
- November 2, 2010
- Decision date
- December 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 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 |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port…OCX · Special | 12/18/2014SE |
| 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 |
Questions and answers
When was Erbeflo 2 Disposable Tubing System cleared by the FDA?
Erbeflo 2 Disposable Tubing System (K103235) received a 510(k) decision of Substantially Equivalent on December 23, 2010, 51 days after the submission was received.
What is the product code of K103235?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.