Tricep
Hooked-Prong Grasping Forceps
21manufacturers in China registered for this device type
10catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Guangdong (5), Zhejiang (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Showing 12 of 21. All 21 manufacturers in China registered for Dislodger, Stone, Basket, Ureteral, Metal
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FFL |
| Device type | Dislodger, Stone, Basket, Ureteral, Metal |
| 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 | 2024-08-09 (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, expiry date |
| Distribution end date | 2024-05-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0063701150 | 3.0 F Diameter | Withdrawn |
| M0063701110 | 0.80 mm Diameter | Withdrawn |
| M0063701190 | 3.0 F Diameter | Withdrawn |
| M0063701180 | 1.0 mm Diameter | Withdrawn |
| M0063701140 | 3.0 F Diameter | Withdrawn |
| M0063701010 | 1.0 mm Diameter | Withdrawn |
| M0063701100 | 90 cm Effective Length | Withdrawn |
| M0063701230 | 1.0 mm Diameter | Withdrawn |
| M0063701220 | 3.0 F Diameter | Withdrawn |
| M0063701000 | 1.0 mm Diameter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gemini | Boston Scientific Corporation | 25 |
| V. Mueller | Carefusion 2200, Inc. | 23 |
| Porges Coloplast | Coloplast A/S | 23 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 22 |
| Captura | Cook Incorporated | 18 |
| Memory Basket | Cook Incorporated | 17 |
| Cook | Cook Incorporated | 17 |
| NCircle | Cook Incorporated | 12 |
| Segura Hemisphere | Boston Scientific Corporation | 9 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 9 |
| Disposable Retrieval Basket | TeleMed Systems | 8 |
| HueRex™ Disposable Stone Retrieval Basket | Shenzhen Hugemed Medical Technical Development Co., Ltd. | 8 |
Showing 12 of 112. All products under Dislodger, Stone, Basket, Ureteral, Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K935737 | 1994-09-07 |
| K935721 | 1994-08-22 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-12-20 | Not classified | Other | The basket wire assembly may detach from the drive wire while in the patient. | 2076 | 2007-05-01 |
| 2005-12-20 | Not classified | Other | The basket wire assembly may detach from the drive wire while in the patient. | 39241 | 2007-05-01 |
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.