FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Clear-Tip EUS-FNA
K Number: K180363
·
Decision Nov 1, 2018
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
11
Review Days
265
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Basic Information
- Device Name
- Clear-Tip EUS-FNA
- K Number
- K180363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Finemedix Co., Ltd.
- Date Received
- February 9, 2018
- Decision Date
- November 1, 2018
- Product Code
- FCG
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCG), ordered by most recent decision date.
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EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
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EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
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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 |
| K202616 | ClearCap Distal Attachment | Feb 19, 2021 | 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 |