ClearCap Distal Attachment
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ClearCap Distal Attachment EUDAMED
- Device Name
- Single-Use Endoscopic Distal Attachment Cap EUDAMED
- Model / Reference
- FM-CC05 EUDAMEDFM-CC03 EUDAMEDFM-CC07 EUDAMEDFM-CC04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809327356171 EUDAMED08809327356157 EUDAMED08809327356195 EUDAMED08809327356164 EUDAMED
- Basic UDI-DI
- 0880932735ECFX EUDAMED
- 510(k) Number
- K202616 FDA 510(k)
- FDA Product Code
- OCX FDA 510(k)
- EMDN Code
- K0180 ENDOTHERAPY DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The ClearCap Distal Attachment is an endoscopic irrigation and suction system accessory, designed as a sterile, single-use distal attachment for endoscopes. It maintains a consistent distance from tissue during endoscopic procedures to ensure an unobstructed visual field, facilitating precise surgical control in gastroenterology and urology applications.
This device is supplied sterile and intended for single-use. It features a conical design with two drainage holes to aid in debris and saline irrigation removal, ensuring clear visibility. Compatible with various endoscope sizes, it is regulated under FDA 510(k) clearance (K202616) and MDR authorization, adhering to Class II medical device standards (regulation number 876.1500).
Frequently asked questions
What types of endoscopic procedures is the ClearCap Distal Attachment designed to assist with, and why is it beneficial in those settings?
The ClearCap Distal Attachment is specifically designed for use in gastroenterology and urology procedures. Its conical shape and two drainage holes help maintain a consistent distance from tissue, ensuring an unobstructed visual field during irrigation and suction. This design reduces debris and saline buildup, improving visibility and precision for surgeons performing delicate procedures like biopsies, polyp removals, or stone fragmentation.
Is the ClearCap Distal Attachment reusable, or is it intended for single-use only? How does this affect its sterility and clinical workflow?
The ClearCap Distal Attachment is intended for single-use only, as explicitly stated in its design. This ensures sterility is maintained out-of-the-box, eliminating the need for reprocessing or cleaning between patients. Clinically, this reduces infection risks and simplifies workflow by avoiding manual sterilization steps, though it does require proper disposal after use.
What sizes or models of endoscopes is the ClearCap Distal Attachment compatible with, and how does this affect its versatility?
While the exact sizing isn’t detailed in the provided data, the device is designed to be compatible with various endoscope sizes, as noted in its specifications. This broad compatibility allows clinicians to use it across different procedures and patient anatomies, enhancing its versatility in both gastroenterology and urology applications without requiring specialized attachments.
How should the ClearCap Distal Attachment be stored to maintain its sterility and functionality before use?
Since the device is supplied sterile, it should be stored in its original, sealed packaging until immediately before use. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and structural integrity. Avoid exposing it to moisture or contamination, as this could compromise its single-use sterility.
What regulatory pathways has the ClearCap Distal Attachment followed, and what does this mean for its use in clinical settings?
The device has undergone FDA 510(k) clearance (K202616) and MDR authorization, classifying it as a Class II medical device under regulation number 876.1500. This means it has been evaluated for safety and performance by regulatory bodies, ensuring compliance with stringent standards before market release. Clinically, this indicates the device meets established requirements for endoscopic irrigation and suction accessories in gastroenterology and urology procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ClearCap Distal Attachment - FINEMEDIX :: 파인메딕스, PDF FINEMEDIX Co., Ltd. Seok-Jun Ma Official Correspondent Trade/Device ..., ClearCap Distal Attachment (K202616) — FDA 510(k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202616 | Class II | Active |
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Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (5)
- FDA 510(k) K202616 24 fields · synced Sep 18, 2026
- EUDAMED c8962b2b-6869-4b69-9a41-b8eebc7470a7 61 fields · synced Jul 11, 2026
- EUDAMED e0a83f58-891c-49e5-a59f-8af559c6dba6 61 fields · synced Jul 13, 2026
- EUDAMED 15bddc6e-de20-4dba-adde-1d62269c6b80 61 fields · synced Jul 15, 2026
- EUDAMED ed8ceadb-f394-441f-b4cd-d32a51805f47 61 fields · synced Jul 22, 2026