Fujifilm
This product is a single-use suction button with built-in suction connector for compatible model FUJIFILM endoscopes. When attached to an endoscope and connected to an aspirator (suction…
This product is a single-use suction button with built-in suction connector for compatible model FUJIFILM endoscopes. When attached to an endoscope and connected to an aspirator (suction source), it is used to control the suctioning of fluids, patient material, etc. through the instrument channel of the endoscope by a medical professional appropriately trained in performing endoscopy. Do not use this product for any other purposes.
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Hangzhou Broncus Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 1 |
| Tianjin Puli Ark Medical Technology Co., Ltd. | Dongli District | Tianjin | Contract manufacturer | 1 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)
Record
| Listed by | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | EOQ |
| Device type | Bronchoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K122535 |
| Record published | 2016-12-14 |
| Record revised | 2025-03-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, High-level Disinfectant |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: There must be no condensation.; Storage environment humidity 30 to 85 % RH; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature 10 to 40 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Box, box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EB-470P | In distribution | |
| EB-530T | In distribution | |
| EB-530H | In distribution | |
| EB-530P | In distribution | |
| SB-602 | In distribution | |
| CA-616 | In distribution | |
| EB-710XT | In distribution | |
| EB-530S | In distribution | |
| EB-710US | In distribution | |
| EB-580S | In distribution | |
| EB-580T | In distribution | |
| B20BU | In distribution | |
| FV-003 | In distribution | |
| EB-710P | In distribution | |
| SB-606 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 248 |
| Pentax | Hoya Corporation | 39 |
| Biopsy Forceps | Olympus Medical Systems Corp. | 31 |
| Single-Use flexible Video Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 27 |
| Pilling | Teleflex Medical LLC | 24 |
| Silicone cap | Efer Endoscopy | 22 |
| Bronchoscope (Flexible Or Rigid) | Intuitive Surgical, Inc. | 20 |
| Endoso | Hunan Endoso Life Technology Co., Ltd. | 20 |
| Exalt ™ | Boston Scientific Corporation | 17 |
| Grasping Forceps | Olympus Medical Systems Corp. | 16 |
| LungVision Tool | Body Vision Medical Ltd | 16 |
| LoopView® | Macrolux Medical Technology Co., Ltd. | 15 |
Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253137 | 2026-06-16 |
| K250863 | 2025-12-12 |
| K244017 | 2025-06-13 |
| K183607 | 2019-08-23 |
| K182253 | 2019-04-04 |
| K182825 | 2019-02-22 |
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.