Identity
- Trade Name
- ClearTip FDA UDI
- Generic Name
- Flexible endoscopic biopsy handpiece/needle FDA UDI
- Device Name
- EUS-FNB 19G FDA UDI
- Model / Reference
- FM-CTB001 FDA UDI
- Description
- EUS-FNB 19G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809327352951 FDA UDI
- 510(k) Number
- K180363 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- Flexible endoscopic biopsy handpiece/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible endoscopic biopsy handpiece/needle
ClearTip by Finemedix Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic biopsy handpiece/needle.
- ViziShot FLEX — Gyrus Acmi, Inc. · Class II
- Disposable Endoscope Injection Needle — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- ELMED — ELMED INCORPORATED · Class I
- Aspirating Biopsy Needle — Auris Health, Inc. · Class II
- Disposable Endoscope Injection Needle — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- Compass Steerable Needle — SERPEX MEDICAL, INC. · Class II
- Disposable Endoscope Injection Needle — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- ClearTip — Finemedix Co., Ltd. · Class II
Cleared under the same submission
K180363 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (1)
- FDA UDI aa7f8ab8-619b-47d3-9cfb-8328869ef0a8 35 fields · synced Jun 8, 2026