AED Sinuscope
FDA 510(k) K170285 · National Advanced Endoscopy Devices, Inc.
510(k) numberK170285
Submission
- Device name
- AED Sinuscope
- Applicant
- National Advanced Endoscopy Devices, Inc.
Canoga Park, CA, US - Received
- January 30, 2017
- Decision date
- August 1, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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|---|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | Stryker Instruments | 06/17/2026SE |
| K254133 | ENTity USB Videoscope SystemEOB · Traditional | Optim, LLC | 05/14/2026SE |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…EOB · Traditional | Zhuhai Wesee Meditech Co., Ltd. | 03/25/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | Olympus Medical Systems Corporation | 03/20/2026SE |
| K241731 | Outlook Surgical Versa One System (8900139)EOB · Traditional | Resnent, LLC | 08/11/2025SE |
| K243639 | Portare System (FA-001)EOB · Traditional | Grumpy Innovation, Inc. | 06/05/2025SE |
| K243380 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional | Olympus Medical Systems Corporation | 03/03/2025SE |
| K234096 | MonoStereoEOB · Traditional | Medicaltek Co., Ltd. | 09/19/2024SE |
| K232435 | Rhinolaryngoscope systemEOB · Traditional | Shenzhen HugeMed Medical Technical Development… | 04/26/2024SE |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional | Atmos Medizintechnik GmbH & Co. KG | 08/03/2023SE |
More from Atmos Medizintechnik GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K141515 | AED Hysteroscope and AccessoriesHIH · Traditional | 01/07/2015SE |
| K102663 | AED ResectoscopeFJL · Traditional | 12/30/2010SE |
| K081553 | AED Bipolar Forceps, Model 13-1646GEI · Traditional | 09/29/2008SE |
| K081503 | AED Monopolar Lap AccessoriesGEI · Traditional | 09/25/2008SE |
| K993689 | AED CystoscopeFAJ · Traditional | 12/15/1999SE |
| K993688 | AED LaparoscopeGCJ · Traditional | 12/06/1999SE |
| K991656 | AED ArthroscopeHRX · Traditional | 12/02/1999SE |
Questions and answers
When was AED Sinuscope cleared by the FDA?
AED Sinuscope (K170285) received a 510(k) decision of Substantially Equivalent on August 1, 2017, 183 days after the submission was received.
What is the product code of K170285?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.