Croc Series Endoscopic Device
Single-use wide angled retrieval device with rat tooth/alligator hybrid jaws and ezSlide® sheath. HIBC/UPN: M453RC9242
44manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
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 | Primed Instruments, Inc., Canada |
|---|---|
| FDA product code | FCL |
| Device type | Forceps, Biopsy, Non-Electric |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-10-23 |
| Record revised | 2019-08-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Biopsy forceps should be stored in the sterile package at room temperature in a clean and dry area away from direct sunl |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H924N | Required Working Channel: 2.8mm | 20 | In distribution |
| H624N | Required Working Channel: 2.8mm | 20 | In distribution |
| H924S | Required Working Channel: 2.8mm | 20 | In distribution |
| H624S | Required Working Channel: 2.8mm | 160 | In distribution |
| RC924 | Required Working Channel: 2.8mm | 5 | In distribution |
| H928N | Required Working Channel: 3.2mm | 20 | In distribution |
| H928S | Required Working Channel: 3.2mm | 160 | In distribution |
| H628N | Required Working Channel: 3.2mm | 20 | In distribution |
| H924N | Required Working Channel: 2.8mm | 160 | In distribution |
| H624N | Required Working Channel: 2.8mm | 160 | In distribution |
| H928N | Required Working Channel: 3.2mm | 160 | In distribution |
| H628S | Required Working Channel: 3.2mm | 160 | In distribution |
| H928S | Required Working Channel: 3.2mm | 20 | In distribution |
| RC924 | Required Working Channel: 2.8mm | 80 | In distribution |
| H628N | Required Working Channel: 3.2mm | 160 | In distribution |
| H628S | Required Working Channel: 3.2mm | 20 | In distribution |
| H924S | Required Working Channel: 2.8mm | 160 | In distribution |
| H624S | Required Working Channel: 2.8mm | 20 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K934186 | 1993-12-14 |
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.