Leakage Tester
"MB-155 Leakage Tester FOR MU-1"
9manufacturers in China registered for this device type
1catalogue number
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 | 2023-12-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MB-155 | 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.