Aed 8800AXS
by National Advanced Endoscopy Devices, Inc.
Aed 8800AXS is a Class II device made by National Advanced Endoscopy Devices, Inc., cleared under FDA 510(k) K170285 on 1 Aug 2017 and listed in FDA GUDID since 24 Nov 2017 (UDI-DI 00848657006354), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00848657006354 | Date24 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170285 | Date1 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 00848657006354
- FDA 510(k) database K170285
Across registries
- FDA 510(k) K170285 decided 1 Aug 2017 Active
- FDA GUDID UDI-DI 00848657006354 listed 24 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K170285
- Listed FDA GUDID 00848657006354
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aed
- Generic name
- Rigid optical sinoscope
- Model / reference
- 8800AXS
- Primary DI / UDI-DI
- 00848657006354
- 510(k) Number
- FDA product code
- EOB
- GMDN term
- Rigid optical sinoscope
- Device class
- Class II
- Regulation number
- 874.4760
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Hydrogen Peroxide
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