Aed 8827AS
by National Advanced Endoscopy Devices, Inc. 2 variants
Aed 8827AS 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 00848657006217), 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 | Number00848657006217 | Date24 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170285 | Date1 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 00848657006217
- FDA 510(k) database K170285
Across registries
- FDA 510(k) K170285 decided 1 Aug 2017 Active
- FDA GUDID UDI-DI 00848657006217 listed 24 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K170285
- Listed FDA GUDID 00848657006217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aed
- Generic name
- Rigid optical sinoscope
- Model / reference
- 8827AS
- Primary DI / UDI-DI
- 00848657006217
- 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
Similar devices
Other devices filed under FDA product code EOB (Nasopharyngoscope (flexible or rigid)).
- 11101HD by Karl Storz SE & CO. KG
- TRANSTYMPANIC ENDOSCOPE by Endooptiks, Inc.
- Olympus WA96201A by Olympus Winter & Ibe GmbH
- KARL STORZ CONTACT MICRO-LARYNGOSCOPES by Karl Storz Endoscopy-America, Inc.
- KSEA UNIMAT 12 by Karl Storz Endoscopy-America, Inc.
- ENDOSHEATH by Vision-Sciences, Inc.
- NASO-LARYNGO-PHARYNGOSCOPE by Schoelly Imaging, Inc.
- InstaClear LCS4K70TPOL by Gyrus Acmi, Inc.
- Olympus WA4KS470 by Olympus Winter & Ibe GmbH
- VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) by Olympus Medical Systems Corporation
Other devices from National Advanced Endoscopy Devices, Inc.
See all devices from National Advanced Endoscopy Devices, Inc. →