510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Spes Medica S.P.A

BATTIPAGLIA Salerno, IT

SPES MEDICA S.P.A appears in FDA device records in BATTIPAGLIA Salerno, IT. FDA records list 9 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
5
Registered establishments
2

510(k) clearance history

FDA records hold 9 510(k) clearances for Spes Medica S.P.A between 2009 and 2022. The busiest year on record is 2019, with 2. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Spes Medica S.P.A, by decision year
YearClearances
20091
20101
20121
20141
20192
20201
20211
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridGYCSubstantially Equivalent
K212326AC Cream - Conductive pasteGYBSubstantially Equivalent
K192606SAC2 - Electrode CreamGYBSubstantially Equivalent
K192603Spes Medica Subdermal Needle ElectrodesGXZSubstantially Equivalent
K190050Tech Dots - Adhesive and conductive gelGYBSubstantially Equivalent
K133348STIM PROBEETNSubstantially Equivalent
K120494DISPOSABLE ADHESIVE SURFACE ELECTRODEGXYSubstantially Equivalent
K093373LARYNGEAL SURFACE ELECTRODEETNSubstantially Equivalent
K091410DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,IKTSubstantially Equivalent

Registered establishments

FDA registered establishments for Spes Medica S.P.A, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30055812203005581220SPES MEDICA S.P.AVIA EUROPA-ZONA INDUSTRIALE, BATTIPAGLIA Salerno 84091 IT2026
30115345333011534533SPES MEDICA S.P.AVia Buccari 21, Genova Liguria 16153 IT2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1971-2021Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.Class IITerminated
Z-1970-2021SNS 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 UE002The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.Class IITerminated
Z-1969-2021Dragonfly 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.The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.Class IITerminated
Z-1968-2021SNS 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 UE006The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.Class IITerminated
Z-1967-2021Dragonfly 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.The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain