Intellijet
Pedestal Pole Intelijet
6manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Anhui (2), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | FWF |
| Device type | Camera, Television, Endoscopic, Without Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-10-22 |
| Record revised | 2023-09-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2017-04-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7205076 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Camera, Television, Endoscopic, Without Audio | Smith & Nephew, Inc. | 30 |
| C-Camsource® | Joimax Gmbh | 10 |
| Hayden Medical | Hayden Medical Inc | 7 |
| Fibre optic cable adpater | Joimax Gmbh | 6 |
| Camsource® | Joimax Gmbh | 6 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 5 |
| Camera, Television, Endoscopic, Without Audio | Pentax of America, Inc. | 4 |
| D-Camsource® | Joimax Gmbh | 4 |
| Gimmi | Gimmi Gmbh | 4 |
| Camera, Television, Endoscopic, Without Audio | Karl Storz GmbH & Co. KG | 3 |
| Camera, Television, Endoscopic, Without Audio | Medos International Sàrl | 3 |
| Camera, Television, Endoscopic, Without Audio | Schölly Fiberoptic GmbH | 3 |
Showing 12 of 33. All products under Camera, Television, Endoscopic, Without Audio
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 |
|---|---|---|---|---|---|
| 2007-01-19 | Not classified | Other | Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT) | 77 units. | 2008-09-02 |
| 2007-01-19 | Not classified | Other | Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT) | 25 units. | 2008-09-02 |
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.