Single Use Electrosurgical Knife
Cutting Knife shape IT type,Cutting Knife length 4mm, Effective working length 2350mm,No injection
7manufacturers in China registered for this device type
21catalogue 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 | Micro-Tech (Nanjing) 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, Contract steriliser, Manufacturer |
| 510(k) | K193601 |
| Record published | 2023-06-28 |
| Record revised | 2025-12-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box, case of 25 |
| Sizes | Length 195 to 235 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MK-O-4-195 | Length 195 cm | In distribution |
| MK-O-4-235 | Length 235 cm | In distribution |
| MK-IT-4-235-N | Length 235 cm | In distribution |
| MK-T-1-235 | Length 235 cm | In distribution |
| MK-I-1-235 | Length 235 cm | In distribution |
| MK-O-2-195 | Length 195 cm | In distribution |
| MK-IT-4-195 | Length 195 cm | In distribution |
| MK-O-1-195 | Length 195 cm | In distribution |
| MK-I-2-195 | Length 195 cm | In distribution |
| MK-T-4-195 | Length 195 cm | In distribution |
| MK-I-1-195 | Length 195 cm | In distribution |
| MK-I-4-195 | Length 195 cm | In distribution |
| MK-T-2-195 | Length 195 cm | In distribution |
| MK-O-2-235 | Length 235 cm | In distribution |
| MK-O-1-235 | Length 235 cm | In distribution |
| MK-T-2-235 | Length 235 cm | In distribution |
| MK-T-1-195 | Length 195 cm | In distribution |
| MK-I-2-235 | Length 235 cm | In distribution |
| MK-I-4-235 | Length 235 cm | In distribution |
| MK-IT-4-195-N | Length 195 cm | In distribution |
| MK-IT-4-235 | Length 235 cm | 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 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 72 |
| 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 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 |
|---|---|
| K210934 | 2021-12-01 |
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.