Disposable Triple Lumen Sphincterotome
14 catalogue numbers from KD-431Q-0720, listed by Olympus Medical Systems Corp., Japan, under Unit, Electrosurgical, Endoscopic (With Or Without Accessories). 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
14catalogue 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 |
| Record published | 2016-09-21 |
| Record revised | 2024-08-07 (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 |
| Distribution end date | 2022-08-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KD-431Q-0720 | In distribution | |
| KD-411Q-0320 | In distribution | |
| KD-411Q-0320 | In distribution | |
| KD-411Q-0730 | In distribution | |
| KD-411Q-0320 | In distribution | |
| KD-431Q-0720 | In distribution | |
| KD-431Q-0720 | In distribution | |
| KD-411Q-0320 | In distribution | |
| KD-401Q-0730 | Withdrawn | |
| KD-401Q-0330 | Withdrawn | |
| KD-431Q-0730 | Withdrawn | |
| KD-401Q-0720 | Withdrawn | |
| KD-401Q-0320 | Withdrawn | |
| KD-411Q-0320 | Withdrawn |
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 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label.
| 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. | 7689 units (7501 US, 188 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. | 887 units (650 US, 237 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. | 886 units (OUS only) |
| 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. | 1072 units (OUS only) |
| 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. | 1490 units (OUS only) |
| 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. | 999 units (OUS only) |
| 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. | 1980 units (OUS only) |
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.