Aed 5700C
by National Advanced Endoscopy Devices, Inc.
Aed 5700C is a rigid optical sinoscope (FDA Class II; FDA product code EOB, Nasopharyngoscope (flexible or rigid)) 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 00848657006224), 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 | Number00848657006224 | Date24 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170285 | Date1 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 00848657006224
- FDA 510(k) database K170285
Across registries
- FDA 510(k) K170285 decided 1 Aug 2017 Active
- FDA GUDID UDI-DI 00848657006224 listed 24 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K170285
- Listed FDA GUDID 00848657006224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aed
- Generic name
- Rigid optical sinoscope
- Model / reference
- 5700C
- Primary DI / UDI-DI
- 00848657006224
- 510(k) Number
- FDA product code
- EOB
- GMDN term
- Rigid optical sinoscope
- Device class
- Class II
- Regulation number
- 874.4760
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Hydrogen Peroxide
Similar devices
Other devices filed under FDA product code EOB (Nasopharyngoscope (flexible or rigid)).
- PENTAX Medical VIVIDEO ENT Videoscope Solution by Pentax Medical Company
- Clearview Scope Cover 28-36000 by Invotec International, Inc.
- KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES by Karl Storz Endoscopy-America, Inc.
- HOPKINS 8706CA by Karl Storz SE & CO. KG
- Medrobotics Flex System by Medrobotics Corporation
- ASAP SINUSCOPE 10-0036-00, 10-0037-00, 10-0038, 10-0039-00, 10-0040-00, 10-0041-00, 10-0042-00, 10-0043-00, 10-0044-00, 10-0045-0 by asap endoscopic products GmbH
- NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS by Olympus America, Inc.
- FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE by RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE by ACCLARENT, INC.
- GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE by Wilson Greatbatch Technologies, Inc.
Other devices from National Advanced Endoscopy Devices, Inc.
See all devices from National Advanced Endoscopy Devices, Inc. →