Identity
- Trade Name
- Disposable Biopsy Valve FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- Disp Biopsy Valve Olym/Fuji Sterile FDA UDI
- Model / Reference
- BW01-OLYB FDA UDI
- Description
- Disp Biopsy Valve Olym/Fuji Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850025860741 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
Yes
FDA UDI
Category: Endoscope working-channel valve, single-use
Disposable Biopsy Valve by Micro-tech Usa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope working-channel valve, single-use.
- Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps — CenterPoint Systems LLC · 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
- SINGLE USE BIOPSY VALVE (Sterile) — Olympus Medical Systems Corporation · 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 (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
- Micro-tech Usa
Sources (1)
- FDA UDI fb1bfc11-f36e-4c5f-8aea-1e4e50e665bd 34 fields · synced Jun 6, 2026