AED Sinuscope
by National Advanced Endoscopy Devices, Inc.
510(k) K170285
AED Sinuscope is a Class II device made by National Advanced Endoscopy Devices, Inc., cleared under FDA 510(k) K170285 on 1 Aug 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170285 | Date1 Aug 2017 | StatusActive |
Official records
- FDA 510(k) database K170285
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EOB
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4760
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K170285
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| AED 22-2717 | 22-2717 | 00848657006170 | — | On the market |
| AED 22-8290 | 22-8290 | 00848657006835 | — | On the market |
| AED 5700A | 5700A | 00848657006200 | — | On the market |
| AED 5700B | 5700B | 00848657006316 | — | On the market |
| AED 5700C | 5700C | 00848657006224 | — | On the market |
| AED 5700F | 5700F | 00848657006231 | — | On the market |
| AED 5700W | 5700W | 00848657006248 | — | On the market |
| AED 5727A | 5727A | 00848657006255 | — | On the market |
| AED 5727B | 5727B | 00848657006262 | — | On the market |
| AED 5727C | 5727C | 00848657006279 | — | On the market |
| AED 5727F | 5727F | 00848657006286 | — | On the market |
| AED 5727W | 5727W | 00848657006293 | — | On the market |
| AED 8314A | 8314A | 00848657077712 | — | On the market |
| AED 8800 | 8800 | 00848657013260 | — | On the market |
| AED 8800A | 8800A | 00848657006361 | — | On the market |
| AED 8800A-HD | 8800A-HD | 00848657076883 | — | On the market |
| AED 8800A-S | 8800A-S | 00848657087247 | — | No longer on the market |
| AED 8800A-S | 8800A-S | 00848657077347 | — | On the market |
| AED 8800AXS | 8800AXS | 00848657006354 | — | No longer on the market |
| AED 8800B | 8800B | 00848657006378 | — | On the market |
| AED 8800B-HD | 8800B-HD | 00848657076890 | — | On the market |
| AED 8800B-R | 8800B-R / 8800B-R | 00848657077149 | — | On the market |
| AED 8800B-R-HD | 8800C-R / 8800B-R-HD | 00848657078139 | — | On the market |
| AED 8800B-S | 8800B-S | 00848657087278 | — | No longer on the market |
| AED 8800B-S | 8800B-S | 00848657077293 | — | On the market |
| AED 8800C | 8800C | 00848657006385 | — | On the market |
| AED 8800C-R | 8800C-R / 8800C-R | 00848657077156 | — | On the market |
| AED 8800C-R-HD | 8800C-R / 8800C-R-HD | 00848657078146 | — | On the market |
| AED 8800C-S | 8800C-S | 00848657087292 | — | No longer on the market |
| AED 8800C-S | 8800C-S | 00848657077279 | — | On the market |
| AED 8800F | 8800F | 00848657006392 | — | On the market |
| AED 8800F-S | 8800F-S | 00848657077255 | — | On the market |
| AED 8800F-S | 8800F-S | 00848657087315 | — | No longer on the market |
| AED 8827A | 8827A | 00848657006323 | — | On the market |
| AED 8827A-S | 8827A-S | 00848657087360 | — | On the market |
| AED 8827AS | 8827AS | 00848657006217 | — | No longer on the market |
| AED 8827AS-S | 8827AS-S | 00848657015202 | — | On the market |
| AED 8827AXS | 8827AXS | 00848657006309 | — | On the market |
| AED 8827B | 8827B | 00848657006347 | — | On the market |
| AED 8827B-S | 8827B-S | 00848657087407 | — | On the market |
| AED 8827BS | 8827BS | 00848657006330 | — | On the market |
| AED 8827BS-S | 8827BS-S | 00848657087421 | — | On the market |
| AED 8827C | 8827C | 00848657087438 | — | On the market |
| AED 8827C | 8827C | 00848657085854 | — | No longer on the market |
| AED 8827CS | 8827CS | 00848657085861 | — | On the market |
| AED 8830A | 8830A | 00848657086462 | — | No longer on the market |
| AED 8830A | 8830A | 00848657077477 | — | On the market |
| AED 8830B | 8830B | 00848657086479 | — | No longer on the market |
| AED 8830B | 8830B | 00848657077460 | — | On the market |
| Hayden Medical 405-450S | 405-450S / 405-450S | 00840319759011 | — | On the market |
Similar devices
Other devices filed under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)).
- ULYSS Multi View Sinuscope by SOPRO-COMEG GmbH
- CITATION SINUSCOPE by Citation Medical Corp.
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- ENT ENDOSCOPES by Global Endoscopy, Inc.
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- TREBAY SCOPE IRRIGATED CLEARING SLEEVE by Trebay Medical Corp.
- VISION SCIENCES FLEXIBLE ENT SCOPE by Vision-Sciences, Inc.
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