ClearCap Distal Attachment
FDA 510(k) K242134 · Finemedix Co., Ltd.
510(k) numberK242134
Submission
- Device name
- ClearCap Distal Attachment
- Applicant
- Finemedix Co., Ltd.
Daegu, KR - Received
- July 22, 2024
- Decision date
- August 20, 2024
- 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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| 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 |
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| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
| 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 |
| K231418 | ENDOGATOR Hybrid Irrigation TubingOCX · Traditional | Medivators | 08/14/2023SE |
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| K202616 | ClearCap Distal AttachmentOCX · Traditional | 02/19/2021SE |
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| K183289 | ClearGrasp SnareFDI · Traditional | 03/06/2019SE |
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Questions and answers
When was ClearCap Distal Attachment cleared by the FDA?
ClearCap Distal Attachment (K242134) received a 510(k) decision of Substantially Equivalent on August 20, 2024, 29 days after the submission was received.
What is the product code of K242134?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.