Forceps, Biopsy, Non-Electric
FLEX. GRASP. FORCEPS 10FR WL 325MM fine-toothed, double action, TL 475 mm, non-dismantling, reusable
44manufacturers in China registered for this device type
28catalogue numbers in this listing
4recalls 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 | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | FCL |
| Device type | Forceps, Biopsy, Non-Electric |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-05-19 |
| Record revised | 2024-11-21 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C |
| Sizes | Length 230 to 1000 mm; outer diameter 1 to 7 mm |
| Distribution end date | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 891360 | Outer Diameter 7.0 mm | In distribution |
| 828651 | Outer Diameter 1 mm | In distribution |
| 82803 | Length 230 mm | In distribution |
| 828051 | Length 550 mm | In distribution |
| 82810 | Length 325 mm | In distribution |
| 895360 | Outer Diameter 1.16666666666 mm | In distribution |
| 82905 | Outer Diameter 1.66666666666 mm | In distribution |
| 8734606 | Length 600 mm | In distribution |
| 8735685 | Outer Diameter 1.66666666666 mm | In distribution |
| 828605 | Length 530 mm | In distribution |
| 82903 | Length 230 mm | In distribution |
| 8968601 | In distribution | |
| 8736685 | Length 550 mm | In distribution |
| 82907 | Length 375 mm | In distribution |
| 829603 | Length 530 mm | In distribution |
| 82805 | Length 315 mm | In distribution |
| 828022 | Length 270 mm | In distribution |
| 8734656 | In distribution | |
| 8734686 | In distribution | |
| 829051 | Length 550 mm | In distribution |
| 829601 | Outer Diameter 1 mm | In distribution |
| 8968671 | Outer Diameter 2 mm | In distribution |
| 82910 | Outer Diameter 3.33333333333 mm | In distribution |
| 82807 | Outer Diameter 2.33333333333 mm | In distribution |
| 7264611 | Length 1000 mm | Withdrawn |
| 829131 | Length 380 mm | Withdrawn |
| 828042 | Length 465 mm | Withdrawn |
| 8642631 | Length 355 mm | Withdrawn |
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 |
| Biopsy Forceps | Taewoongmedical.co., Ltd. | 28 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 26 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 25 |
Showing 12 of 117. All products under Forceps, Biopsy, Non-Electric
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Richard Wolf Gmbh | UDI-DI | 2023-03-24 | Class II | Under Investigation by firm | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the e | 838 units |
| Richard Wolf Gmbh | UDI-DI | 2023-03-24 | Class II | Under Investigation by firm | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the e | 342 units |
| Richard Wolf Gmbh | UDI-DI | 2023-03-24 | Class II | Under Investigation by firm | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the e | 319 units |
| Richard Wolf Gmbh | UDI-DI | 2023-03-24 | Class II | Under Investigation by firm | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the e | 280 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.