Single Use Electrosurgical Knife KD-612
The Olympus KD-612 electrosurgical knife cuts tissue within the digestive tract using high-frequency current. It is used with a compatible Olympus endoscope, power cable and electrosurgical…
The Olympus KD-612 electrosurgical knife cuts tissue within the digestive tract using high-frequency current. It is used with a compatible Olympus endoscope, power cable and electrosurgical unit.
The instrument has a handle with a slider and an insertion portion containing a stainless-steel cutting knife within a sheath. Pushing the slider extends the knife from the sheath, and pulling it retracts the knife. The endoscope carries the instrument to the treatment site.
Supply
The KD-612L and KD-612U are supplied sterile following ethylene-oxide processing and are intended for a single use. Their knife function requires the compatible electrosurgical energy source.
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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | KNS |
| Device type | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4300 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K250351 |
| Record published | 2025-11-19 |
| Record revised | 2025-11-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KD-612L | In distribution | |
| KD-612L | In distribution | |
| KD-612U | In distribution | |
| KD-612U | In distribution | |
| KD-612U | In distribution | |
| KD-612L | 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 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 |
Showing 12 of 177. All products under Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252889 | 2025-11-25 |
| K250945 | 2025-10-17 |
| K250351 | 2025-10-10 |
| K193039 | 2019-12-17 |
| K182408 | 2019-05-15 |
| K171158 | 2017-11-17 |
| K160241 | 2016-03-02 |
| K150142 | 2015-10-08 |
| K122505 | 2013-04-11 |
| K092309 | 2009-10-30 |
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.