Identity
- Trade Name
- AED FDA UDI
- Generic Name
- Rigid optical sinoscope FDA UDI
- Device Name
- AED Endoscope - Sinuscope 2.70mm x 30 degree, 180mm FDA UDI
- Model / Reference
- 5727B FDA UDI
- Description
- AED Endoscope - Sinuscope 2.70mm x 30 degree, 180mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848657006262 FDA UDI
- 510(k) Number
- K170285 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Rigid optical sinoscope 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hydrogen Peroxide FDA UDI
Category: Rigid optical sinoscope
Aed by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical sinoscope.
- JEDMED — JEDMED Instrument Company · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- SINUSCOPE — Ecleris · Class II
- JEDMED — JEDMED Instrument Company · Class II
- JEDMED — JEDMED Instrument Company · Class II
- PrimeSight — SCHÖLLY FIBEROPTIC GmbH · Class II
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
Cleared under the same submission
K170285 also covers:
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
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 |
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Manufacturer
- Manufacturer
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 3a5849be-ce4d-4d53-acdf-80088c93e58e 34 fields · synced May 30, 2026