Dislodger, Stone, Biliary
The FDA filing identifies the proposed device as a Disposable Stone Extraction Basket and classifies it under the biliary stone-disloger product code. The device has a basket at the distal…
The FDA filing identifies the proposed device as a Disposable Stone Extraction Basket and classifies it under the biliary stone-disloger product code.
The device has a basket at the distal end of a catheter sheath, operated through a handle actuator to extend and retract it. The catheter sheath is single-lumen PTFE, with the basket advanced and retracted through it by a handle.
Use and Construction
The filing states that the basket is used endoscopically to remove biliary stones and foreign bodies, and that the device is single-use.
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 | Hangzhou AGS MedTech Co., Ltd., China |
|---|---|
| FDA product code | LQR |
| Device type | Dislodger, Stone, Biliary |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K201509 |
| Record published | 2022-10-09 |
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, manufacturing date |
| Packaging | Box of 10, carton of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AG-5062-N2524G | In distribution | |
| AG-5062-N2024G | In distribution | |
| AG-5063-S2524G | In distribution | |
| AG-5062-N3024G | 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 |
| 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 |
| 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 |
|---|---|
| K201509 | 2020-12-16 |
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.