Single-Use Extraction Baskets
The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system.
5manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
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 | Scivita Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | LQR |
| Device type | Dislodger, Stone, Biliary |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Manufacturer |
| 510(k) | K240192 |
| Record published | 2024-12-06 |
| Record revised | 2025-09-29 (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, manufacturing date |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 20 to 80 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -40 to 55 °C; Storage environment humidity 20 to 80 % RH |
| Packaging | Pack of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EBF-1508CG | In distribution | |
| EBF-1506SG | In distribution | |
| EBF-1529SG | In distribution | |
| EBF-2006SG | In distribution | |
| EBF-1511CG | In distribution | |
| EBF-1507SG | In distribution | |
| EBF-1511SG | In distribution | |
| EBF-2007CG | In distribution | |
| EBF-2007SG | In distribution | |
| EBF-2029CG | In distribution | |
| EBF-1508SG | In distribution | |
| EBF-2008CG | In distribution | |
| EBF-2008SG | In distribution | |
| EBF-2006CG | In distribution | |
| EBF-2029SG | In distribution | |
| EBF-1506CG | In distribution | |
| EBF-1507CG | In distribution | |
| EBF-1529CG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| eyeMAX(TM) Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | 35 |
| Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | 15 |
| Memory | Cook Incorporated | 10 |
| Memory Basket | Cook Incorporated | 6 |
| Stonetome | Boston Scientific Corporation | 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 |
|---|---|
| K240192 | 2024-10-15 |
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.