NCompass
NCompass Nitinol Stone Extractor
5manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
2recalls 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 | Cook Incorporated, United States |
|---|---|
| FDA product code | LQR |
| Device type | Dislodger, Stone, Biliary |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-09-14 |
| Record revised | 2020-11-06 (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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G36251 | 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 |
| 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 |
Showing 12 of 22. All products under Dislodger, Stone, Biliary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171915 | 2018-03-01 |
| K173687 | 2017-12-15 |
| K170898 | 2017-12-12 |
| K173009 | 2017-11-07 |
| K902944 | 1990-09-12 |
| K902945 | 1990-09-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cook Incorporated | UDI-DI | 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 70 units |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 49 units |
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.