Radial Jaw 4
14 catalogue numbers from M00513410, listed by Boston Scientific Corporation, United States, under Forceps, Biopsy, Non-Electric. 44 manufacturers in China are registered for this product code.
44manufacturers in China registered for this device type
14catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (18), Zhejiang (14), Shanghai (4). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
Showing 12 of 44. All 44 manufacturers in China registered for Forceps, Biopsy, Non-Electric
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FCL |
| Device type | Forceps, Biopsy, Non-Electric |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-02-12 (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 |
| Packaging | Pack of 20, pack of 40, pack of 5, pack of 80 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00513410 | 2.8 mm Diameter | In distribution |
| M00513310 | 2.8 mm Diameter | In distribution |
| M00513340 | 3.2 mm Diameter | In distribution |
| M00513370 | 3.2 mm Diameter | In distribution |
| M00513330 | 2.8 mm Diameter | In distribution |
| M00513450 | 2.0 mm Diameter | In distribution |
| M00513440 | 2.0 mm Diameter | In distribution |
| M00513300 | 2.8 mm Diameter | In distribution |
| M00513400 | 2.8 mm Diameter | In distribution |
| M00513390 | 2.8 mm Diameter | In distribution |
| M00513320 | 2.8 mm Diameter | In distribution |
| M00513360 | 3.2 mm Diameter | In distribution |
| M00513380 | 2.8 mm Diameter | In distribution |
| M00513350 | 3.2 mm Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Forceps, Biopsy, Non-Electric | Hangzhou AGS MedTech Co., Ltd. | 384 |
| Disposable Endoscopic Biopsy Forceps | Ningbo Xinwell Medical Technology Co., Ltd. | 384 |
| Single Use Biopsy Forceps | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 224 |
| Surgical Direct | Surgical Direct, Inc. | 153 |
| Surtex | Surtex Instruments Ltd | 129 |
| Single-Use Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 81 |
| Disposable Biopsy Forceps | Olympus Medical Systems Corp. | 60 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 48 |
| Optimos™ Biopsy Forceps | Taewoongmedical.co., Ltd. | 28 |
| Forceps, Biopsy, Non-Electric | Richard Wolf Gmbh | 28 |
| Biopsy Forceps | Taewoongmedical.co., Ltd. | 28 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 26 |
Showing 12 of 117. All products under Forceps, Biopsy, Non-Electric
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Boston Scientific Corporation | UDI-DI | 2026-06-30 | Class II | Process control | Potential for breach in sterile barrier of device packaging. | 5,020 (US); 20,770 (OUS) |
| Boston Scientific Corporation | UDI-DI | 2026-06-30 | Class II | Process control | Potential for breach in sterile barrier of device packaging. | 5,020 (US); 20,770 (OUS) |
| Boston Scientific Corporation | UDI-DI | 2026-06-30 | Class II | Process control | Potential for breach in sterile barrier of device packaging. | 5,020 (US); 20,770 (OUS) |
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 |
|---|---|---|---|---|---|
| 2010-05-06 | Not classified | Process control | Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result. | 2011-09-20 | |
| 2010-05-06 | Not classified | Process control | Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result. | 2011-09-20 | |
| 2010-05-06 | Not classified | Process control | Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result. | 320 units | 2011-09-20 |
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.