Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K191878
DEX Device · Dex Surgical · decided 2021-01-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Arm Needle holder | B-1301 | DEX SURGICAL | GEI | 03665772000060 |
| Sleeve applicator tool | P46732 | DEX SURGICAL | GEI | 03665772000053 |
| Control handle | P-1301 | DEX SURGICAL | GEI | 03665772000015 |
| Arm Monopolar hook | B-1506 | DEX SURGICAL | GEI | 03665772000091 |
| Monopolar protection sleeve | M-1304 | DEX SURGICAL | GEI | 03665772000046 |
| Control Unit | E-1301 | DEX SURGICAL | GEI | 03665772000008 |
| Control Handle Left | P-1302 | DEX SURGICAL | GEI | 03665772000022 |
| Protection sleeve | 2090-MDS | DEX SURGICAL | GEI | 03665772000039 |
| Arm Monopolar scissors | B-1304 | DEX SURGICAL | GEI | 03665772000077 |
| Arm Monopolar Maryland | B-1505 | DEX SURGICAL | GEI | 03665772000084 |