Ultratome XL
Triple Lumen Sphincterotome
7manufacturers in China registered for this device type
4catalogue numbers in this listing
8510(k) clearances naming this product code
13recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FDI |
| Device type | Snare, Flexible |
| 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 |
|---|---|---|
| M00535920 | 5.5 F Diameter | In distribution |
| M00535910 | 5.5 F Diameter | In distribution |
| M00535930 | 30 mm Effective Length | In distribution |
| M00535900 | 20 mm Effective Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Snare, Flexible | Hangzhou AGS MedTech Co., Ltd. | 125 |
| Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 58 |
| ClearGrasp Snare | Finemedix | 36 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 30 |
| Disposable Polypectomy Snare | TeleMed Systems | 29 |
| Polypectomy Snare | Micro-Tech (Nanjing) Co., Ltd. | 20 |
| Roth Net | Us Endoscopy | 15 |
| EdgeHog(TM) Polypectomy Snare | Micro-Tech (Nanjing) Co., Ltd. | 14 |
| Halyard | Avanos Medical, Inc. | 11 |
| Singular | ConMed Corporation | 10 |
| Disposable Polyp Snare | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 10 |
| Multiple Loop Polypectomy Snare | Avanos Medical, Inc. | 8 |
Showing 12 of 61. All products under Snare, Flexible
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202478 | 2020-10-08 |
| K160637 | 2016-03-30 |
| K140726 | 2014-07-21 |
| K133987 | 2014-01-24 |
| K131700 | 2013-11-04 |
| K950496 | 1995-03-30 |
| K941750 | 1994-11-01 |
| K930022 | 1993-04-27 |
Recalls
13 of these are Class II. 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 | Closed |
|---|---|---|---|---|---|
| 2021-01-19 | Class II | Process change control | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. | 335,788 units total (Domestic: 222,882, Foreign: 112,906) | |
| 2021-01-19 | Class II | Process change control | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. | 335,788 units total (Domestic: 222,882, Foreign: 112,906) | |
| 2021-01-19 | Class II | Process change control | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. | 335,788 units total (Domestic: 222,882, Foreign: 112,906) | |
| 2020-07-06 | Class II | Device Design | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding | ||
| 2020-07-06 | Class II | Device Design | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding | ||
| 2020-07-06 | Class II | Device Design | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding | ||
| 2020-07-06 | Class II | Device Design | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding | ||
| 2020-07-06 | Class II | Device Design | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding | ||
| 2020-07-06 | Class II | Device Design | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding | ||
| 2020-07-06 | Class II | Device Design | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding | ||
| 2012-05-16 | Class II | Process control | Difficulty in extending snare loop from the catheter | 1970 units | 2013-02-28 |
| 2012-05-16 | Class II | Process control | Difficulty in extending snare loop from the catheter | 1340 units | 2013-02-28 |
| 2012-05-16 | Class II | Process control | Difficulty in extending snare loop from the catheter | 2760 units | 2013-02-28 |
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.