Aed 18-2304
by National Advanced Endoscopy Devices, Inc.
Aed 18-2304 is a Class II device made by National Advanced Endoscopy Devices, Inc., cleared under FDA 510(k) K141515 on 7 Jan 2015 and listed in FDA GUDID since 30 Nov 2017 (UDI-DI 00848657016162), active 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 | Number00848657016162 | Date30 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141515 | Date7 Jan 2015 | StatusActive |
Official records
- AccessGUDID record 00848657016162
- FDA 510(k) database K141515
Across registries
- FDA 510(k) K141515 decided 7 Jan 2015 Active
- FDA GUDID UDI-DI 00848657016162 listed 30 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K141515
- Listed FDA GUDID 00848657016162
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aed
- Generic name
- Endoscope sheath, reusable
- Model / reference
- 18-2304
- Primary DI / UDI-DI
- 00848657016162
- 510(k) Number
- FDA product code
- HIH
- GMDN term
- Endoscope sheath, reusable
- Device class
- Class II
- Regulation number
- 884.1690
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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