Single Use Sphincterotome V(Distal Wireguided)
Single Use Sphincterotome V (Distal Wireguided)
7manufacturers in China registered for this device type
20catalogue numbers in this listing
10510(k) clearances naming this product code
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) | K160241 |
| Record published | 2018-09-18 |
| Record revised | 2026-02-17 (version 8) |
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 |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KD-VC412Q-0215 | In distribution | |
| KD-VC411Q-0320 | In distribution | |
| KD-VC411Q-0330 | In distribution | |
| KD-VC411Q-0320 | In distribution | |
| KD-VC431Q-0720 | In distribution | |
| KD-VC433Q-0730 | In distribution | |
| KD-VC433Q-0720 | In distribution | |
| KD-VC411Q-0330 | In distribution | |
| KD-VC411Q-0730 | In distribution | |
| KD-VC411Q-0730 | In distribution | |
| KD-VC431Q-0730 | In distribution | |
| KD-VC431Q-0720 | In distribution | |
| KD-VC411Q-0720 | In distribution | |
| KD-VC411Q-0330 | In distribution | |
| KD-VC411Q-0320 | In distribution | |
| KD-VC431Q-0730 | In distribution | |
| KD-VC411Q-0720 | In distribution | |
| KD-VC431Q-0720 | In distribution | |
| KD-VC412Q-0215 | In distribution | |
| KD-VC431Q-0730 | 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 |
| 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 |
|---|---|
| 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 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2026-01-07 | Class II | Process control | Devices which did not undergo thermoforming could deform and lose performance. | 12641 units (8789 US, 3852 OUS) |
| Olympus Corporation of the Americas | UDI-DI | 2026-01-07 | Class II | Process control | Devices which did not undergo thermoforming could deform and lose performance. | 4183 units (821 US, 3362 OUS) |
| Olympus Corporation of the Americas | UDI-DI | 2026-01-07 | Class II | Process control | Devices which did not undergo thermoforming could deform and lose performance. | 10008 units (3038 US, 6970 OUS) |
| Olympus Corporation of the Americas | UDI-DI | 2026-01-07 | Class II | Process control | Devices which did not undergo thermoforming could deform and lose performance. | 10257 units (274 US, 9983 OUS) |
| Olympus Corporation of the Americas | UDI-DI | 2026-01-07 | Class II | Process control | Devices which did not undergo thermoforming could deform and lose performance. | 5946 units (2208 US, 3738 OUS) |
| Olympus Corporation of the Americas | UDI-DI | 2026-01-07 | Class II | Process control | Devices which did not undergo thermoforming could deform and lose performance. | 5089 units (30 US, 5059 OUS) |
| Olympus Corporation of the Americas | 510(k) number | 2026-01-07 | Class II | Process control | Devices which did not undergo thermoforming could deform and lose performance. | 1918 units (413 US, 1505 OUS) |
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.