Company ยท IT
Spes Medica Srl
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2022. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 10, 2022 | K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Map Spes Medica Srl, IT | GYC |
| Dec 1, 2021 | K212326 | AC Cream - Conductive paste Spes Medica Srl, IT | GYB |
| Jan 17, 2020 | K192606 | SAC2 - Electrode Cream Spes Medica Srl, IT | GYB |
| Nov 22, 2019 | K192603 | Spes Medica Subdermal Needle Electrodes Spes Medica Srl, IT | GXZ |
| Jul 19, 2019 | K190050 | Tech Dots - Adhesive and conductive gel Spes Medica Srl, IT | GYB |
| Nov 21, 2014 | K133348 | STIM PROBE Spes Medica Srl, IT | ETN |
| Jun 11, 2012 | K120494 | DISPOSABLE ADHESIVE SURFACE ELECTRODE Spes Medica Srl, IT | GXY |
| Aug 24, 2010 | K093373 | LARYNGEAL SURFACE ELECTRODE Spes Medica Srl, IT | ETN |
| Aug 11, 2009 | K091410 | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, Spes Medica Srl, IT | IKT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2021 | Spes Medica Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring. Terminated |
ETN | K133348 |
| Apr 8, 2021 | Spes Medica SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number Terminated |
FAP | K113771 |
| Apr 8, 2021 | Spes Medica Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures. Terminated |
ETN | K093373 |
| Apr 8, 2021 | Spes Medica SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number Terminated |
FAP | K113771 |
| Apr 8, 2021 | Spes Medica Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures. Terminated |
ETN | K093373 |