Identity
- Trade Name
- Disposable Endoscopy Adapter Set FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Sentrus Endoscopy Adapter Set, Olympus disposable valve and adapter set (3pc) FDA UDI
- Model / Reference
- FTL-VS-O-B FDA UDI
- Description
- Sentrus Endoscopy Adapter Set, Olympus disposable valve and adapter set (3pc) FDA UDI
Identifiers
- Catalog Number
- SEN-EAS-O-3 FDA UDI
- Primary DI / UDI-DI
- 06936603231067 FDA UDI
- 510(k) Number
- K220210 FDA UDI
- FDA Product Code
- ODC FDA UDI
- GMDN Term
- Endoscope channel support kit 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 channel support kit
Disposable Endoscopy Adapter Set by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Endoscope channel support kit.
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- CeroFrict — SML Med-Tech Solutions Limited · Class II
- CeroFrict — SML Med-Tech Solutions Limited · 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 799b6811-3023-4c25-904d-de7c9953af6b 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026