Rotatable Biopsy Forceps
Catalogue number FB-54KR-1, listed by Olympus Medical Systems Corp., Japan, under Forceps, Biopsy, Non-Electric. 44 manufacturers in China are registered for this product code.
44manufacturers in China registered for this device type
1catalogue number
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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FCL |
| Device type | Forceps, Biopsy, Non-Electric |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2022-08-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-08-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FB-54KR-1 | 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 |
| 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
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.