FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ClearCap Distal Attachment
K Number: K202616
·
Decision Feb 19, 2021
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
11
Review Days
163
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Basic Information
- Device Name
- ClearCap Distal Attachment
- K Number
- K202616
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Finemedix Co., Ltd.
- Date Received
- September 9, 2020
- Decision Date
- February 19, 2021
- Product Code
- OCX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Finemedix Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251478 | ClearTip TBNA Type | Apr 16, 2026 | Substantially Equivalent |
| K250994 | ClearTip FNA and FNB Types | Aug 21, 2025 | Substantially Equivalent |
| K242857 | ClearHemograsper | May 21, 2025 | Substantially Equivalent |
| K242134 | ClearCap Distal Attachment | Aug 20, 2024 | Substantially Equivalent |
| K231267 | ClearTip | Jun 30, 2023 | Substantially Equivalent |
| K200217 | ClearEndoclip | Oct 5, 2020 | Substantially Equivalent |
| K183021 | ClearEndoclip | Jun 28, 2019 | Substantially Equivalent |
| K183289 | ClearGrasp Snare | Mar 6, 2019 | Substantially Equivalent |
| K181690 | Clear-Jet Injection Catheter | Dec 21, 2018 | Substantially Equivalent |
| K180363 | Clear-Tip EUS-FNA | Nov 1, 2018 | Substantially Equivalent |