Identity
- Trade Name
- FIBER LARYNGOSCOPE FDA UDI
- Generic Name
- Flexible fibreoptic nasopharyngolaryngoscope FDA UDI
- Device Name
- FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED) FDA UDI
- Model / Reference
- FNL-15RP3 FDA UDI
- Description
- FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333232789 FDA UDI
- 510(k) Number
- K921707 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Flexible fibreoptic nasopharyngolaryngoscope 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible fibreoptic nasopharyngolaryngoscope
Fiber Laryngoscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic nasopharyngolaryngoscope.
- PENTAX — HOYA CORPORATION · Class II
- PENTAX — HOYA CORPORATION · Class II
- RHINO-LARYNGO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
- Henke-Sass Wolf — H & A Mui Enterprises Inc · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- RHINO-LARYNGO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K921707 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
- PENTAX of America, Inc.
Sources (1)
- FDA UDI d528e892-9d1b-4170-96e1-055033b39c15 34 fields · synced May 30, 2026