Stone Cone
Nitinol Urological Retrieval Coil
2manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Innovex Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FGO |
| Device type | Dislodger, Stone, Flexible |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4680 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
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 |
|---|---|---|
| M0063903200 | 10 mm Diameter | In distribution |
| M0063903100 | 3 F Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gyrus Acmi | Gyrus Acmi, Inc. | 41 |
| Dornier MedTech | Dornier Medtech America, Inc. | 13 |
| Olympus | Gyrus Acmi, Inc. | 7 |
| Dislodger, Stone, Flexible | Stryker GmbH | 5 |
| Falcon | Us Endoscopy | 2 |
| Talon | Us Endoscopy | 2 |
| USA Elite | Gyrus Acmi, Inc. | 2 |
| Gyrus Icmi | Gyrus Acmi, Inc. | 1 |
| Stone Retrieval Basket | Applied Medical Resources Corp. | 1 |
| Soltive | Gyrus Acmi, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970121 | 1997-04-02 |
| K963750 | 1996-11-22 |
| K951309 | 1995-05-17 |
| K885168 | 1989-09-08 |
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.