Hydratome RX 49
4 catalogue numbers from M00583000, listed by Boston Scientific Corporation, United States, 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
4catalogue numbers in this listing
18510(k) clearances naming this product code
40recalls on this 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 | Boston Scientific Corporation, United States |
|---|---|
| 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2021-01-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00583000 | 0.89 mm Diameter | In distribution |
| M00583020 | 0.035 in Diameter | In distribution |
| M00583010 | 0.035 in Diameter | In distribution |
| M00583030 | 0.89 mm Diameter | 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 |
|---|---|
| K262460 | 2026-09-03 |
| K250584 | 2025-06-11 |
| K232633 | 2023-11-28 |
| K233318 | 2023-10-27 |
| K232162 | 2023-08-14 |
| K231533 | 2023-06-21 |
| K200404 | 2020-12-03 |
| K133933 | 2014-04-02 |
| K122203 | 2012-08-17 |
| K110887 | 2011-04-14 |
| K013153 | 2001-10-19 |
| K002802 | 2000-10-05 |
| K973826 | 1997-12-05 |
| K970278 | 1997-04-11 |
| K970053 | 1997-03-28 |
| K961349 | 1996-05-15 |
| K942301 | 1994-11-02 |
| K885005 | 1989-02-01 |
Recalls
6 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-12-19 | Class I | Process control | Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious | 588 units |
| 2025-12-19 | Class I | Process control | Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious | 266 units |
| 2025-12-19 | Class I | Process control | Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious | 557 units |
| 2025-12-19 | Class I | Process control | Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious | 150 units |
| 2025-12-19 | Class I | Process control | Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious | 59 units |
| 2025-12-19 | Class I | Process control | Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious | 39 units |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 309 units |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 38 units |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 47 units |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 495 units US; 2 units(OUS) |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 118 units (OUS) |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 1144 units US; 60 units (OUS) |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 1102 units (OUS) |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 519 units (OUS) |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 1530 units (OUS) |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 91 units (OUS) |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 12 units |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 1399 units; 20 units (OUS) |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 31 units |
| 2024-12-20 | Class II | Process control | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | 263 units (OUS) |
| 2024-06-12 | Class II | Process control | Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure. | 256 US, 39 OUS |
| 2023-02-02 | Class II | Under Investigation by firm | Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the | 6635 units US: 1815 US units; 4820 OUS units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 7115 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 4487 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 3578 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 21309 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 15 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 3371 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 98 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 142 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 254 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 14 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 3578 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 98 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 32 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 12067 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 1447 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 367 units |
| 2021-12-22 | Class II | Packaging process control | Sterility of device is compromised due to a sterile barrier breach | 500 units |
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.