Ksea Quadro Switch
FDA 510(k) K021776 · Karl Storz Endoscopy
510(k) numberK021776
Submission
- Device name
- Ksea Quadro Switch
- Applicant
- Karl Storz Endoscopy
Culver City, CA, US - Received
- May 29, 2002
- Decision date
- August 15, 2002
- 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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| K242586 | ArgoCap (200.52)OCX · Traditional | Ovesco Endoscopy AG | 05/22/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | Hangzhou AGS MedTech Co., Ltd. | 03/20/2025SE |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902)OCX · Traditional | Olympus Medical Systems Corporation | 10/07/2024SE |
| 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 |
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| K043375 | Fisch Titanium Middle Ear ProsthesesETA · Traditional | 01/24/2005SE |
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| K030009 | Ksea Powershaver System S2HRX · Traditional | 04/02/2003SE |
| K023924 | Autocon II 200 Electrosurgical GeneratorGEI · Traditional | 02/21/2003SE |
| K023187 | Ksea SpinoscopeHRX · Traditional | 12/02/2002SE |
| K011700 | Modulith SLK LithotripterLNS · Traditional | 08/16/2002SE |
| K013107 | Bioabsorbable Interference Screw MegafixHWC · Traditional | 02/26/2002SE |
| K011841 | Ksea Sawahle Electromechanical MorcellatorGCJ · Traditional | 09/10/2001SE |
| K010569 | Ksea Universal Laparomat Laparoscopic Suction and Irrigation PumpGCJ · Traditional | 04/09/2001SE |
| K004037 | X-Ray System Xr-MxJAA · Traditional | 02/02/2001SE |
Questions and answers
When was Ksea Quadro Switch cleared by the FDA?
Ksea Quadro Switch (K021776) received a 510(k) decision of Substantially Equivalent on August 15, 2002, 78 days after the submission was received.
What is the product code of K021776?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.