Sphincterotome Short-Wire Compatible
Sphincterotome / short-wire compatible, lumen 3, TIP length 2mm, cutting wire 30mm, Outside diameter 2.5mm, Cone, no half Insulation, preload 4.5m guidewire, Single Cutting wire, Tip…
Sphincterotome / short-wire compatible, lumen 3, TIP length 2mm, cutting wire 30mm, Outside diameter 2.5mm, Cone, no half Insulation, preload 4.5m guidewire, Single Cutting wire, Tip diameter:4.9Fr
7manufacturers in China registered for this device type
73catalogue 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 | 2023-04-03 |
| Record revised | 2025-12-04 (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 | Atherectomy device tip length 2 to 5 mm; atherectomy cutter length 20 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RDSP-0525-211 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-111 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0230-221 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0530-211-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-232 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-131-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-231 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0225-111 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0530-232 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-112 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-222 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0230-131 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0520-111-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0230-111 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0520-231-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-132 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-132 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-211-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-212 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-131 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0230-231-2 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0525-111-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-231 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-121-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-222 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0220-211 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0525-112 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-221 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-222 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-211-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-232 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-231-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0220-111 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0525-121-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-221 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0230-211 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0530-111 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-121 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-211 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0220-221 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0525-212 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-112 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0225-131 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0530-231 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-131 | In distribution | |
| RDSP-0225-221 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0530-121 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-221 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0230-121 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0230-231 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0530-122 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0220-231 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0520-211 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-221-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-231-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-122 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0225-211 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0220-131 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0520-131-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-111-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0530-131 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0525-221-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-121-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-212 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0225-231 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0530-131-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-121 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0220-121 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0525-111 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-122 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0225-121 | Atherectomy Device Tip Length 2 mm | In distribution |
| RDSP-0530-221-1 | Atherectomy Device Tip Length 5 mm | In distribution |
| RDSP-0520-132 | Atherectomy Device Tip Length 5 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 |
| 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 |
| 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.