Biopsy Valve
"MD-495 Semi Disp Valve FOR BF-1T20D/P20"
9manufacturers in China registered for this device type
4catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Sumitomo Bakelite (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FDS |
| Device type | Gastroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2024-07-25 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Ethylene Oxide, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MB-358 | 10 | In distribution | |
| MD-495 | 10 | In distribution | |
| MD-495 | 10 | In distribution | |
| MB-358 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pentax | Hoya Corporation | 72 |
| Fujifilm | Fujifilm Corporation | 43 |
| Disposable Distal Attachment | Olympus Medical Systems Corp. | 27 |
| Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 26 |
| Video Gastroscope | Pentax of America, Inc. | 20 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 18 |
| Medisono | Medisono, LLC | 18 |
| Gastroscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 17 |
| Distal Attachment | Olympus Medical Systems Corp. | 14 |
| Disposable EMR KIT | Olympus Medical Systems Corp. | 12 |
| Fuse® | Endochoice, Inc. | 11 |
| Evis Exera II Gastrointestinal Videoscope | Olympus Medical Systems Corp. | 9 |
Showing 12 of 66. All products under Gastroscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260824 | 2026-08-27 |
| K260856 | 2026-08-27 |
| K250296 | 2025-05-01 |
| K232997 | 2024-06-19 |
| K123317 | 2012-12-11 |
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.