Zksk
Disposable Ligation Device
7manufacturers in China registered for this device type
48catalogue numbers in this listing
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 | Beijing Zksk Technology Co., Ltd., China |
|---|---|
| FDA product code | MND |
| Device type | Ligator, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K213223 |
| Record published | 2023-12-28 |
| Record revised | 2023-08-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HE15-195-1 | In distribution | |
| HE30-230-3 | In distribution | |
| HE40-230-3 | In distribution | |
| HE15-230-2 | In distribution | |
| HE20-165-3 | In distribution | |
| BL18-6A | In distribution | |
| BL18-7A | In distribution | |
| BL18-9A | In distribution | |
| HE40-195-1 | In distribution | |
| HE15-195-2 | In distribution | |
| HE20-195-2 | In distribution | |
| HE40-230-1 | In distribution | |
| HE15-230-3 | In distribution | |
| HE20-195-1 | In distribution | |
| BL18-5A | In distribution | |
| HE30-165-1 | In distribution | |
| HE40-230-2 | In distribution | |
| BL18-6A | In distribution | |
| BL18-5A | In distribution | |
| HE20-230-2 | In distribution | |
| BL18-7A | In distribution | |
| HE30-230-2 | In distribution | |
| BL18-4A | In distribution | |
| HE40-165-1 | In distribution | |
| HE20-230-1 | In distribution | |
| HE30-195-2 | In distribution | |
| HE40-165-3 | In distribution | |
| HE15-230-1 | In distribution | |
| HE15-165-3 | In distribution | |
| HE40-165-2 | In distribution | |
| HE20-165-2 | In distribution | |
| HE40-195-2 | In distribution | |
| HE30-230-1 | In distribution | |
| HE30-165-3 | In distribution | |
| HE15-165-2 | In distribution | |
| HE15-165-1 | In distribution | |
| HE20-165-1 | In distribution | |
| HE20-195-3 | In distribution | |
| HE40-195-3 | In distribution | |
| BL18-9A | In distribution | |
| BL18-4A | In distribution | |
| HE20-230-3 | In distribution | |
| HE30-165-2 | In distribution | |
| BL18-8A | In distribution | |
| BL18-8A | In distribution | |
| HE30-195-3 | In distribution | |
| HE30-195-1 | In distribution | |
| HE15-195-3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Stiegmann-Goff Bandito | ConMed Corporation | 1 |
Showing 12 of 17. All products under Ligator, Esophageal
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.