Identity
- Trade Name
- Laryngoskop FS2 FDA UDI
- Generic Name
- Flexible video nasopharyngoscope FDA UDI
- Device Name
- This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage tester and connection for light source port. The handle incorporates the control lever to bend the distal tip. The picture is the region under examination is imaged by an optical unit. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- This flexible fibre scope is designed with the flexible insertion tube with its bendable distal tip, the handle with the leakage tester and connection for light source port. The handle incorporates the control lever to bend the distal tip. The picture is the region under examination is imaged by an optical unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B809M105220300700 FDA UDI
- 510(k) Number
- K150248 FDA UDI
- FDA Product Code
- EQN FDA UDI
- GMDN Term
- Flexible video nasopharyngoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible video nasopharyngoscope
Laryngoskop FS2 by orlvision GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video nasopharyngoscope.
- JEDMED — JEDMED Instrument Company · Class II
- Flexible Video Rhino Laryngoscope — orlvision GmbH · Class II
Cleared under the same submission
K150248 also covers:
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
- Manufacturer
- orlvision GmbH
Sources (2)
- FDA UDI 9e034905-89b0-4974-b931-5d834f662cca 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026