AED
AED Ultima HD Sinuscope, 4mm x 17.5cm, 70 Degree, Reverse Light Post | 8800C-R-HD
7manufacturers in China registered for this device type
49catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Hunan (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Hunan Vathin Medical Instrument Co., Ltd. | Xiangtan | Hunan | Manufacturer | 6 |
| Jiana Sterilization Technology (Changsha) Co., Ltd. | Changsha | Hunan | Contract manufacturer | 4 |
| Zhuhai Wesee Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 2 |
| Liaoning Jrsd Commercial AND Trading Co., Ltd. | Shenyang | Liaoning | Manufacturer | 2 |
Record
| Listed by | National Advanced Endoscopy Devices, Inc., United States |
|---|---|
| FDA product code | EOB |
| Device type | Nasopharyngoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4760 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K170285 |
| Record published | 2017-11-24 |
| Record revised | 2023-11-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2025-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5727F | In distribution | |
| 8827A-S | In distribution | |
| 8800B-HD | In distribution | |
| 8800A-HD | In distribution | |
| 8800C | In distribution | |
| 8800F | In distribution | |
| 8827B | In distribution | |
| 5700A | In distribution | |
| 8800B-S | In distribution | |
| 8830B | In distribution | |
| 5700C | In distribution | |
| 8800A | In distribution | |
| 8800C-R-HD | In distribution | |
| 8800 | In distribution | |
| 5727W | In distribution | |
| 8827AXS | In distribution | |
| 8827BS-S | In distribution | |
| 5700F | In distribution | |
| 8800B | In distribution | |
| 8800F-S | In distribution | |
| 5700W | In distribution | |
| 8314A | In distribution | |
| 8830A | In distribution | |
| 22-8290 | In distribution | |
| 8827B-S | In distribution | |
| 8827C | In distribution | |
| 8800B-R-HD | In distribution | |
| 5727A | In distribution | |
| 8827A | In distribution | |
| 8800B-R | In distribution | |
| 8827AS-S | In distribution | |
| 5727C | In distribution | |
| 22-2717 | In distribution | |
| 8800C-R | In distribution | |
| 8827BS | In distribution | |
| 8827CS | In distribution | |
| 5700B | In distribution | |
| 8800A-S | In distribution | |
| 8800C-S | In distribution | |
| 5727B | In distribution | |
| 8827AS | Withdrawn | |
| 8800A-S | Withdrawn | |
| 8800B-S | Withdrawn | |
| 8800C-S | Withdrawn | |
| 8830A | Withdrawn | |
| 8830B | Withdrawn | |
| 8800AXS | Withdrawn | |
| 8800F-S | Withdrawn | |
| 8827C | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 174 |
| Hopkins | Karl Storz GmbH & Co. KG | 99 |
| Jedmed | Jedmed Instrument Company | 70 |
| Endo-Scrub® | Medtronic Xomed, Inc. | 51 |
| Sinuscope | Sopro-Comeg GmbH | 32 |
| Sharpsite | Medtronic Xomed, Inc. | 30 |
| Slide-ON® | Medtronic Xomed, Inc. | 29 |
| Slide-ON® Endosheath® | Medtronic Xomed, Inc. | 28 |
| Sinuscope | Ecleris SRL | 27 |
| Nasopharyngoscope (Flexible Or Rigid) | Pentax of America, Inc. | 26 |
| Flex | Medrobotics Corporation | 24 |
| Prosidio | Prosidio LLC | 23 |
Showing 12 of 147. All products under Nasopharyngoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170285 | 2017-08-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.