FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ClearEndoclip
K Number: K200217
·
Decision Oct 5, 2020
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
62
Applicant Total
11
Review Days
251
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Basic Information
- Device Name
- ClearEndoclip
- K Number
- K200217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Finemedix Co., Ltd.
- Date Received
- January 28, 2020
- Decision Date
- October 5, 2020
- Product Code
- PKL
- 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 |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKL), ordered by most recent decision date.
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
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OTSCneo System Set (100.03n-14n, 100.27n-31n)
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FDA Class 2
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FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dual Action Tissue Closure Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K202616 | ClearCap Distal Attachment | Feb 19, 2021 | 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 |