Sterile Sphincterotome
Sterile Sphincterotome/ lumen 3/ TIP length 2/ cutting wire 25/ Outside diameter 2.5mm/ Front end shape/ no Rotation/ no half Insulation / no preload guidewire/ Single Cutting wire
7manufacturers in China registered for this device type
40catalogue 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) | K210934 |
| Record published | 2022-12-31 |
| Record revised | 2025-12-18 (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, case of 10 |
| Sizes | Atherectomy device tip length 2 to 5 mm; atherectomy cutter length 5 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSP-30530-111111 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30525-111121 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30505-121221 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30225-111112 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30525-111221 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30520-111221 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30225-111111 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30220-111111 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30505-121121 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30520-111121 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30505-121211 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30225-111211 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30525-111211 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30225-111121 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30220-111222 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30530-111221 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30230-111222 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30220-111211 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30525-111111 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30230-111211 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30220-111221 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30230-111112 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30225-111122 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30225-111222 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30505-121111 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30520-111211 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30225-111221 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30220-111212 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30520-111111 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30220-111112 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30230-111212 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30230-111111 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30225-111212 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30230-111122 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30530-111211 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30230-111121 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30220-111121 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30530-111121 | Atherectomy Device Tip Length 5 mm | In distribution |
| DSP-30220-111122 | Atherectomy Device Tip Length 2 mm | In distribution |
| DSP-30230-111221 | Atherectomy Device Tip Length 2 mm | 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 |
| 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 |
|---|---|
| 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.