Identity
- Trade Name
- Disposable Biopsy Valve FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Model / Reference
- FTL-BV-F-EO/FTL-BV-O-EO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936603225615 FDA UDI
- 510(k) Number
- K220210 FDA UDI
- FDA Product Code
- ODC FDA UDI
- GMDN Term
- Endoscope working-channel valve, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope working-channel valve, single-use
Disposable Biopsy Valve by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Endoscope working-channel valve, single-use.
- Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps — CenterPoint Systems LLC · Class II
- Disposable Biopsy Valve — Micro-tech Usa · Class II
- Edge — Covidien LP · Class II
- CONMED CLEARGUARD — Conmed Corporation · Class II
- Edge — Covidien LP · Class II
- Edge — Covidien LP · Class II
- BioShield — US Endoscopy · Class II
- Edge — Covidien LP · Class II
Cleared under the same submission
K220210 also covers:
- 3-Piece Valve Kit — Micro-tech Usa
- 3-Piece Valve Kit — Micro-tech Usa
- 3-Piece Valve Kit — Micro-tech Usa
- 4-Piece Valve Kit — Micro-tech Usa
- 4-Piece Valve Kit — Micro-tech Usa
- 4-Piece Valve Kit — Micro-tech Usa
- 4-Piece Valve Kit — Micro-tech Usa
- 5-Piece Valve Kit — Micro-tech Usa
- 5-Piece Valve Kit — Micro-tech Usa
- 5-Piece Valve Kit — Micro-tech Usa
- Auxiliary Water Connector — Micro-tech Usa
- Auxiliary Water Connector — Micro-tech Usa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI f193a631-c289-4265-993e-e0d7e43c2b2d 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026