Speedband Superview Super 7
Multiple Band Ligator
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Beijing (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | MND |
| Device type | Ligator, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 2, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00542250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zksk | Beijing Zksk Technology Co., Ltd. | 48 |
| Saeed | Cook Incorporated | 27 |
| Multiple Band Ligator Set | Micro-Tech (Nanjing) Co., Ltd. | 24 |
| Single Use Rotatable Clip Fixing Device | Olympus Medical Systems Corp. | 22 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 10 |
| Auto-Band® | Endochoice, Inc. | 4 |
| Tube Sheath | Olympus Medical Systems Corp. | 3 |
| Rotatable Clip Fixing Device | Olympus Medical Systems Corp. | 3 |
| Stiegmann-Goff | ConMed Corporation | 3 |
| Ligating Device | Olympus Medical Systems Corp. | 3 |
| Loop | Olympus Medical Systems Corp. | 2 |
| Single USE Ligating Device | Olympus Medical Systems Corp. | 2 |
Showing 12 of 17. All products under Ligator, Esophageal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K990864 | 1999-06-11 |
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.