Single Use 3-Lumen Extraction Balloon V
5 catalogue numbers from B-V233P-B, listed by Olympus Medical Systems Corp., Japan, under Dislodger, Stone, Biliary. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
5catalogue numbers in this listing
3510(k) clearances naming this product 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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | LQR |
| Device type | Dislodger, Stone, Biliary |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K091495 |
| Record published | 2016-09-21 |
| Record revised | 2025-11-24 (version 6) |
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 |
| Packaging | Pack of 15 |
| Distribution end date | 2022-08-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B-V233P-B | In distribution | |
| B-V233P-A | In distribution | |
| B-V233P-B | Withdrawn | |
| B-V243Q-B | Withdrawn | |
| B-V443Q-A | Withdrawn |
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 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 |
|---|---|
| K243807 | 2025-03-18 |
| K170811 | 2017-11-27 |
| K091495 | 2009-09-03 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Aomori Olympus Co., Ltd. Kuroishi Site | 510(k) number | 2021-01-04 | Class II | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | 7,400,000 (global); 260,395 (US) | 2024-03-11 |
| Aomori Olympus Co., Ltd. Kuroishi Site | 510(k) number | 2021-01-04 | Class II | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | 7,400,000 (global); 260,395 (US) | 2024-03-11 |
| Aomori Olympus Co., Ltd. Kuroishi Site | 510(k) number | 2021-01-04 | Class II | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | 7,400,000 (global); 260,395 (US) | 2024-03-11 |
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.