ClearCap Distal Attachment
FDA 510(k) K202616 · Finemedix Co., Ltd.
510(k) numberK202616
Submission
- Device name
- ClearCap Distal Attachment
- Applicant
- Finemedix Co., Ltd.
Daegu, KR - Received
- September 9, 2020
- Decision date
- February 19, 2021
- 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.
Other 510(k)s with product code OCX
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|---|---|---|---|
| K251986 | Auxiliary Water Tube MAJ-855OCX · Traditional | Olympus Medical Systems Corporation | 09/26/2025SE |
| K251997 | Single-Use Biopsy Valve (MAJ-1555)OCX · Traditional | Olympus Medical Systems Corporation | 09/25/2025SE |
| 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 |
More from Zhejiang Chuangxiang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251478 | ClearTip TBNA TypeKTI · Traditional | 04/16/2026SE |
| K250994 | ClearTip FNA and FNB TypesFCG · Traditional | 08/21/2025SE |
| K242857 | ClearHemograsperKGE · Traditional | 05/21/2025SE |
| K242134 | ClearCap Distal AttachmentOCX · Special | 08/20/2024SE |
| K231267 | ClearTipFCG · Traditional | 06/30/2023SE |
| K200217 | ClearEndoclipPKL · Traditional | 10/05/2020SE |
| K183021 | ClearEndoclipPKL · Traditional | 06/28/2019SE |
| K183289 | ClearGrasp SnareFDI · Traditional | 03/06/2019SE |
| K181690 | Clear-Jet Injection CatheterFBK · Traditional | 12/21/2018SE |
| K180363 | Clear-Tip EUS-FNAFCG · Traditional | 11/01/2018SE |
Questions and answers
When was ClearCap Distal Attachment cleared by the FDA?
ClearCap Distal Attachment (K202616) received a 510(k) decision of Substantially Equivalent on February 19, 2021, 163 days after the submission was received.
What is the product code of K202616?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.