Fuse
Water bottle cap with CO2, Reusable
9manufacturers in China registered for this device type
52catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dalian Create Medical Products Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 2 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Endochoice, Inc., Canada |
|---|---|
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2017-08-11 |
| Record revised | 2024-01-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 133 to 168 cm |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FSC330-A6334-R | Withdrawn | |
| LS-FSC330-F7526 | Length 168 cm | Withdrawn |
| FSC330-F7523-R | Withdrawn | |
| LS-FSC330-G7521 | Length 133 cm | Withdrawn |
| FSC330-F7525 | Length 150 cm | Withdrawn |
| SCT-468 | Withdrawn | |
| FDEMO-F7524 | Length 133 cm | Withdrawn |
| FSC330-C6332-R | Withdrawn | |
| FSC330-G7520-R | Withdrawn | |
| FSC330-F7527 | Length 133 cm | Withdrawn |
| LS-FSC330-F7524 | Length 133 cm | Withdrawn |
| FSC330-C6333-R | Withdrawn | |
| FSC330-C6337-R | Withdrawn | |
| FSC330-G7529 | Length 168 cm | Withdrawn |
| FSC330-G7530 | Length 133 cm | Withdrawn |
| FDEMO-F7525 | Length 150 cm | Withdrawn |
| FSC330-F7523 | Length 168 cm | Withdrawn |
| SCT-468-02 | Withdrawn | |
| FSC330-G7522-R | Withdrawn | |
| SCT-469 | Withdrawn | |
| FSC330-F7526-R | Withdrawn | |
| FDEMO-G7522 | Length 150 cm | Withdrawn |
| FSC330-G7531 | Length 150 cm | Withdrawn |
| FDEMO-F7526 | Length 168 cm | Withdrawn |
| FSC-3300-SL-R | Withdrawn | |
| FSC-3300-150-R | Withdrawn | |
| FDEMO-G7529 | Length 168 cm | Withdrawn |
| FDEMO-G7521 | Length 133 cm | Withdrawn |
| FDEMO-F7523 | Length 168 cm | Withdrawn |
| FSC330-G7522 | Length 150 cm | Withdrawn |
| FSC330-A6336-R | Withdrawn | |
| FDEMO-G7520 | Length 168 cm | Withdrawn |
| SCT-469-02 | Withdrawn | |
| FSC330-G7520 | Length 168 cm | Withdrawn |
| FSC330-F7528 | Length 150 cm | Withdrawn |
| FSC330-F7524 | Length 133 cm | Withdrawn |
| FSC330-F7526 | Length 168 cm | Withdrawn |
| LS-FSC330-G7529 | Length 168 cm | Withdrawn |
| FSC330-C6339-R | Withdrawn | |
| FDEMO-F7528 | Length 150 cm | Withdrawn |
| FSC-3300-133-R | Withdrawn | |
| LS-FSC330-G7520 | Length 168 cm | Withdrawn |
| LS-FSC330-F7525 | Length 150 cm | Withdrawn |
| FSC330-G7521-R | Withdrawn | |
| FSC330-G7521 | Length 133 cm | Withdrawn |
| LS-FSC330-G7522 | Length 150 cm | Withdrawn |
| FSC330-F7524-R | Withdrawn | |
| FSC330-F7525-R | Withdrawn | |
| FSC330-G7529-R | Withdrawn | |
| FSC330-C6338-R | Withdrawn | |
| LS-FSC330-F7523 | Length 168 cm | Withdrawn |
| FSC-3300-ST-R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 51 |
| Fujifilm | Fujifilm Corporation | 40 |
| Pentax | Hoya Corporation | 37 |
| Video Colonoscope | Pentax of America, Inc. | 25 |
| G-EYE Colonoscope | Smart Medical Systems Ltd. | 24 |
| Medisono | Medisono, LLC | 18 |
| Evis Exera lll Colonovideoscope | Olympus Medical Systems Corp. | 16 |
| Endoch | Endoch Inc | 14 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonoscope And Accessories, Flexible/Rigid | Hangzhou AGS MedTech Co., Ltd. | 10 |
| Flex | Medrobotics Corporation | 10 |
Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141598 | 2014-09-30 |
| K132839 | 2014-02-06 |
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.