Endoflip
Refurbished 300 Pump System With Pre-Use Tube
1manufacturer
17catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Medical Technologies (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| 510(k) | K231861 |
| Record published | 2023-08-24 |
| Record revised | 2026-05-20 (version 17) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Fragile, Keep dry, This side up; Storage environment temperature -30 to 60 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 20 to 40 °C; Handling environment humidity 15 to 95 % RH; Storage environment humidity 15 to 95 % RH |
| Packaging | Pack_or_inner_pack of 5, case of 5, box of 5 |
| Distribution end date | 2026-04-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EF-301 | In distribution | |
| EF-325N | In distribution | |
| EF-322N | In distribution | |
| EF-322N | In distribution | |
| EF-304 | In distribution | |
| EF-302 | In distribution | |
| LK-103 | In distribution | |
| EF-100 | In distribution | |
| EF-303 | In distribution | |
| DD-961 | In distribution | |
| EF-301-RFB | In distribution | |
| LK-200 | In distribution | |
| EF-325N | In distribution | |
| RFG-EF100 | In distribution | |
| EF-305 | In distribution | |
| DD-961 | Withdrawn | |
| EF-100 | Power, +12, VDC; Power, 80, VA; | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mui Scientific | H&A Mui Enterprises, Inc. | 771 |
| UniTip High Resolution Catheter | Unisensor AG | 183 |
| UniTip Catheter | Unisensor AG | 100 |
| ManoScan | Given Imaging Ltd. | 60 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 27 |
| inSIGHT Ultima | Diversatek Healthcare Inc | 19 |
| Sitzmarks Radiopaque Markers | Konsyl Pharmaceuticals, Inc. | 14 |
| Zvu® | Diversatek Healthcare Inc | 11 |
| Distender II Barostat | G & J Electronics, Inc. | 9 |
| PriZm | Diversatek Healthcare Inc | 8 |
| ManoView | Given Imaging Ltd. | 6 |
| System, Gastrointestinal Motility (Electrical) | Given Imaging Ltd. | 6 |
Showing 12 of 107. All products under System, Gastrointestinal Motility (Electrical)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2026-05-13 | Class II | Under Investigation by firm | Due to products are incorrectly flagged as expired due to the system’s 24-hour usage limit, rendering the product unavailable for clinical procedures. | 327 |
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.