Stonetome
Stone Removal Device
5manufacturers in China registered for this device type
6catalogue numbers in this listing
6510(k) clearances naming this product code
9recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Zhejiang Soudon Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 9 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | LQR |
| Device type | Dislodger, Stone, Biliary |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| 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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00535130 | 1.8 mm Diameter | In distribution |
| M00535210 | 5.5 F Diameter | In distribution |
| M00535150 | 1.8 mm Diameter | In distribution |
| M00535190 | 1.8 mm Diameter | In distribution |
| M00535170 | 1.8 mm Diameter | In distribution |
| M00535110 | 20 mm Effective Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| eyeMAX(TM) Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | 35 |
| Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | 18 |
| Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | 15 |
| Memory | Cook Incorporated | 10 |
| Memory Basket | Cook Incorporated | 6 |
| Single Use 3-Lumen Extraction Balloon V | Olympus Medical Systems Corp. | 5 |
| Single Use Retrieval Basket V | Olympus Medical Systems Corp. | 4 |
| Dislodger, Stone, Biliary | Hangzhou AGS MedTech Co., Ltd. | 4 |
| Cook | Cook Incorporated | 3 |
| CardioFIT | Karl Storz GmbH & Co. KG | 2 |
| VedBasket, Stone Extraction Baskets | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2 |
| Dislodger, Stone, Biliary | Karl Storz GmbH & Co. KG | 2 |
Showing 12 of 22. All products under Dislodger, Stone, Biliary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203322 | 2021-05-26 |
| K191789 | 2019-07-25 |
| K071066 | 2007-06-29 |
| K946358 | 1995-04-11 |
| K925879 | 1993-02-08 |
| K925495 | 1992-12-23 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-01-08 | Not classified | Packaging | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated. | 294 of all products. | 2009-10-22 |
| 2009-01-08 | Not classified | Packaging | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated. | 294 of all products. | 2009-10-22 |
| 2009-01-08 | Not classified | Packaging | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated. | 294 of all products. | 2009-10-22 |
| 2006-05-19 | Not classified | Other | Lack of assurance of sterility, as the sterile barrier may fail. | 2007-06-20 | |
| 2006-05-19 | Not classified | Other | Lack of assurance of sterility, as the sterile barrier may fail. | 2007-06-20 | |
| 2006-05-19 | Not classified | Other | Lack of assurance of sterility, as the sterile barrier may fail. | 2007-06-20 | |
| 2006-05-19 | Not classified | Other | Lack of assurance of sterility, as the sterile barrier may fail. | 2007-06-20 | |
| 2006-05-19 | Not classified | Other | Lack of assurance of sterility, as the sterile barrier may fail. | 2007-06-20 | |
| 2006-05-19 | Not classified | Other | Lack of assurance of sterility, as the sterile barrier may fail. | 2007-06-20 |
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.