Clearpath 24
FDA 510(k) K112318 · Promedic, Inc.
510(k) numberK112318
Submission
- Device name
- Clearpath 24
- Applicant
- Promedic, Inc.
Bonita Springs, FL, US - Received
- August 11, 2011
- Decision date
- June 29, 2012
- 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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|---|---|---|---|
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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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Questions and answers
When was Clearpath 24 cleared by the FDA?
Clearpath 24 (K112318) received a 510(k) decision of Substantially Equivalent on June 29, 2012, 323 days after the submission was received.
What is the product code of K112318?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.