Zksk
Disposable Sphincterotome
7manufacturers in China registered for this device type
72catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
| Zhejiang Soudon Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 9 |
Record
| Listed by | Beijing Zksk Technology Co., Ltd., China |
|---|---|
| FDA product code | KNS |
| Device type | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4300 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K242192 |
| Record published | 2026-05-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECK19-25-05-230 | In distribution | |
| ECK18-30-15-180 | In distribution | |
| ECK19-25-05-180 | In distribution | |
| ECK18-20-05-200 | In distribution | |
| ECK18-30-05-180 | In distribution | |
| ECK18-20-15-230 | In distribution | |
| ECK19-20-10-180 | In distribution | |
| ECK19-10-10-180 | In distribution | |
| ECK18-30-15-230 | In distribution | |
| ECK19-20-05-180 | In distribution | |
| ECK18-10-05-200 | In distribution | |
| ECK19-10-05-200 | In distribution | |
| ECK18-20-05-180 | In distribution | |
| ECK18-25-10-180 | In distribution | |
| ECK19-20-15-230 | In distribution | |
| ECK18-30-10-180 | In distribution | |
| ECK18-20-10-200 | In distribution | |
| ECK19-10-15-180 | In distribution | |
| ECK19-30-15-230 | In distribution | |
| ECK19-10-15-230 | In distribution | |
| ECK18-10-10-180 | In distribution | |
| ECK19-20-15-200 | In distribution | |
| ECK18-10-10-200 | In distribution | |
| ECK18-20-15-200 | In distribution | |
| ECK19-20-10-200 | In distribution | |
| ECK18-10-15-180 | In distribution | |
| ECK19-30-05-180 | In distribution | |
| ECK19-25-10-230 | In distribution | |
| ECK19-10-05-230 | In distribution | |
| ECK18-10-05-180 | In distribution | |
| ECK19-25-10-200 | In distribution | |
| ECK18-30-05-200 | In distribution | |
| ECK18-10-05-230 | In distribution | |
| ECK19-30-10-180 | In distribution | |
| ECK18-25-15-230 | In distribution | |
| ECK18-25-05-200 | In distribution | |
| ECK18-25-15-200 | In distribution | |
| ECK19-25-15-200 | In distribution | |
| ECK19-25-15-230 | In distribution | |
| ECK18-20-15-180 | In distribution | |
| ECK19-10-15-200 | In distribution | |
| ECK19-30-05-200 | In distribution | |
| ECK18-10-10-230 | In distribution | |
| ECK18-30-10-200 | In distribution | |
| ECK19-10-10-230 | In distribution | |
| ECK19-10-05-180 | In distribution | |
| ECK19-30-10-200 | In distribution | |
| ECK19-20-05-200 | In distribution | |
| ECK18-25-10-200 | In distribution | |
| ECK18-20-10-230 | In distribution | |
| ECK18-25-15-180 | In distribution | |
| ECK18-25-10-230 | In distribution | |
| ECK19-25-05-200 | In distribution | |
| ECK18-30-10-230 | In distribution | |
| ECK19-25-10-180 | In distribution | |
| ECK19-20-15-180 | In distribution | |
| ECK19-20-10-230 | In distribution | |
| ECK19-30-10-230 | In distribution | |
| ECK19-30-15-200 | In distribution | |
| ECK18-25-05-180 | In distribution | |
| ECK19-30-15-180 | In distribution | |
| ECK19-20-05-230 | In distribution | |
| ECK18-20-05-230 | In distribution | |
| ECK19-10-10-200 | In distribution | |
| ECK18-30-05-230 | In distribution | |
| ECK18-10-15-230 | In distribution | |
| ECK18-10-15-200 | In distribution | |
| ECK18-30-15-200 | In distribution | |
| ECK18-20-10-180 | In distribution | |
| ECK19-30-05-230 | In distribution | |
| ECK18-25-05-230 | In distribution | |
| ECK19-25-15-180 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 93 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Hangzhou AGS MedTech Co., Ltd. | 73 |
| Sphincterotome short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | 73 |
| Single Use Preloaded Sphincterotome V(Distal Wireguided) | Olympus Medical Systems Corp. | 40 |
| Single Use Preloaded Sphincterotome V | Olympus Medical Systems Corp. | 40 |
| Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 40 |
| Single Use 3-Lumen Sphincterotome V | Olympus Medical Systems Corp. | 37 |
| Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 21 |
| Single Use Sphincterotome V(Distal Wireguided) | Olympus Medical Systems Corp. | 20 |
| Cook | Cook Incorporated | 18 |
| Olympus | Olympus Winter & IBE Gmbh | 18 |
| ezSnare Polypectomy Snare | Endo-Therapeutics, Inc. | 18 |
Showing 12 of 177. All products under Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242192 | 2025-02-06 |
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.