Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- ETKTube, Toynbee Diagnostic1Product Code
- ETMGustometer, Sterile1Product Code
- ETNStimulator, Nerve2Product Code
- K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)2Cleared 510(K)
- K233001Bioscope Neuromonitor Device2Cleared 510(K)
- K241917EARP Nerve Cuff Electrode2Cleared 510(K)
- K232888Disposable Laryngeal Electrodes2Cleared 510(K)
- K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube2Cleared 510(K)
- K230853EARP Nerve Cuff Electrode2Cleared 510(K)
- K231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)2Cleared 510(K)
- K223254C2 Xplore2Cleared 510(K)
- K212164Mapping Suction Probe2Cleared 510(K)
- K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long2Cleared 510(K)
- K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large2Cleared 510(K)
- K200886StimSite2Cleared 510(K)
- K152769FREMAP ELECTRODE2Cleared 510(K)
- K152505C2 NerveMonitor System2Cleared 510(K)
- K150005Checkpoint, Checkpoint Head & Neck2Cleared 510(K)
- K133348STIM PROBE2Cleared 510(K)
- K140400ES2 NEUROMONITORING ACCESSORY INSTRUMENTS2Cleared 510(K)
- K122040INVOTEC LARYNGEAL ELECTRODE2Cleared 510(K)
- K121931NONDISPOSABLE STIMULATING INSTRUMENTS2Cleared 510(K)
- K121257LARYNGEAL ELECTRODE2Cleared 510(K)
- K112686NEXT GEN EMG ENDOTRACHEAL TUBE2Cleared 510(K)
- K112717NUVASIVE NVJJB SYSTEM2Cleared 510(K)
- K112426XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES2Cleared 510(K)
- K112718NUVASIVE NVM5 SYSTEM2Cleared 510(K)
- K112709STIMULATION/DISSECTION INSTRUMENTS2Cleared 510(K)
- K111671SEASPINE MONOPOLAR PROBE SYSYEM2Cleared 510(K)
- K110989NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE2Cleared 510(K)
- K111597DISPOSABLE STIMULATING ELECTRODE2Cleared 510(K)
- K112435RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT2Cleared 510(K)
- K110696NEURO CHECK DEVICE WITH IO-FLEX WIRE2Cleared 510(K)
- K110712DRYTOUCH SUCTION STIMULATOR PROBE2Cleared 510(K)
- K110422SURGICAL STIMULATORS2Cleared 510(K)
- K110138PAIRED HYDROGEL ELECTRODE2Cleared 510(K)
- K103128CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,2Cleared 510(K)
- K102862NEUROVISION SE (NERVEANA)2Cleared 510(K)
- K100992NEURALMAS2Cleared 510(K)
- K093373LARYNGEAL SURFACE ELECTRODE2Cleared 510(K)
- K091874INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 5306562Cleared 510(K)
- K092292CHECKPOINT2Cleared 510(K)
- K092729BAXANO NEURO CHECK DEVICE2Cleared 510(K)
- K083242NEUROSIGN AVALANCHE MOTOR NERVE MONITOR2Cleared 510(K)
- K090838STIMULUS/DISSECTION INSTRUMENTS2Cleared 510(K)
- K081742BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.252Cleared 510(K)
- K072736RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT2Cleared 510(K)
- K071349NEUROSIGN LARYNGEAL ELECTRODES2Cleared 510(K)
- K063560HILGER DUAL-STIM NERVE STIMULATOR2Cleared 510(K)
- K063305STIMULATING BUR GUARD2Cleared 510(K)
- K062549XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 1052382Cleared 510(K)
- K061365CHECKPOINT WITH ACCUSTIM TECHNOLOGY2Cleared 510(K)
- K053141NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 8002Cleared 510(K)
- K051718NUVASIVE NEUROVISION JJB SYSTEM2Cleared 510(K)
- K050162CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE2Cleared 510(K)
- K040543NUVASIVE NEUROVISION JJB SYSTEM2Cleared 510(K)
- K032083NUVASIVE NEUROVISION JJB SYSTEM2Cleared 510(K)
- K031510NIM-SPINE2Cleared 510(K)
- K031003STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES2Cleared 510(K)
- K021595GYRUS ENT NERVE STIMULATOR2Cleared 510(K)
- K020955NICOLET ELECTROCAUTERY DETECTOR2Cleared 510(K)
- K014165STIMULUS - DISSECTION INSTRUMENTS2Cleared 510(K)
- K010213MODIFICATION TO CAVERMAP SURGICAL AID2Cleared 510(K)
- K003745LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET2Cleared 510(K)
- K000507CAVERMAP SURGICAL AID2Cleared 510(K)
- K992869XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE2Cleared 510(K)
- K991583NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR2Cleared 510(K)
- K982595NIM42Cleared 510(K)
- K980148NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR2Cleared 510(K)
- K970971URO MED NERVE STIMULATOR2Cleared 510(K)
- K971143NEURO PULSE II,III2Cleared 510(K)
- K964869NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR2Cleared 510(K)
- K954601NERVE LOCATOR/MONITOR SYSTEM MODIFICATION2Cleared 510(K)
- K945799NEUROSIGN 100 IMPEDANCE METER2Cleared 510(K)
- K951641NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR2Cleared 510(K)
- K945242NERVE MONITOR ELECTRODES/STIMULATOR PROBES2Cleared 510(K)
- K934733STIMULATING SURGICAL INSTRUMENTS2Cleared 510(K)
- K934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)2Cleared 510(K)
- K933491R AND D BATTERIES, INC. PART NOS. 5038 & 53472Cleared 510(K)
- K925640XOMED-TREACE EMG ENDOTRACHEAL TUBEEN2Cleared 510(K)
- K925008RLN NERVE LOCATOR/MONITOR; MODEL A2Cleared 510(K)
- K923056NEUROSIGN MODEL 1002Cleared 510(K)
- K912508NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION2Cleared 510(K)
- K905035AXOSTIM NERVE STIMULATOR, MODIFICATION2Cleared 510(K)
- K905045NERVE LOCATOR/STIMULATOR2Cleared 510(K)
- K895838BRACKMANN EMG MONITORING SYSTEM2Cleared 510(K)
- K894930DENTEC 40002Cleared 510(K)
- K895676HEMOSTAT/STIMULATOR PROBE2Cleared 510(K)
- K881757RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS2Cleared 510(K)
- K874018NEUROPROBE2Cleared 510(K)
- K880720MONTGOMERY NERVE STIMULATOR2Cleared 510(K)
- K873964NICOLET DISPOSABLE PRASS PROBE2Cleared 510(K)
- K872791POREX NERVE LOCATOR2Cleared 510(K)
- K870272MODEL 6110C OTOPHOR2Cleared 510(K)
- K843226EVOKED RESPONSE ELECTRICAL STIMULATOR2Cleared 510(K)
- K833646PULSATRON NERVE LOCATOR/STIMULATOR2Cleared 510(K)
- K831715NEUROTRAC2Cleared 510(K)
- K781569NERVE LOCATER/STIMULATOR2Cleared 510(K)
- ETPStimulator, Caloric-Water1Product Code
- ETRAdaptor, Short Increment Sensitivity Index (Sisi)1Product Code
- ETSGenerator, Electronic Noise (For Audiometric Testing)2Product Code
- ETTCushion, Earphone (For Audiometric Testing)1Product Code
- ETYTester, Auditory Impedance2Product Code
- EWASet, Audiometer Calibration1Product Code
- EWCChamber, Acoustic (For Audiometric Testing)1Product Code
- EWOAudiometer2Product Code
- KHHStimulator, Caloric-Air1Product Code
- KLXElectroglottograph2Product Code
- LYNApparatus, Visual Reinforcement Audiometric2Product Code
- NASTympanometer2Product Code
- NNJGustometer, Non-Sterile1Product Code
- NRKKit, Test, Olfactory2Product Code
- PTOTester, Auditory Impedance, Exempt2Product Code
- PTPTympanometer, Exempt2Product Code
- LWIUltrasound, Sinus2Product Code
- PSVUltrasound Bronchoscope2Product Code
- QJGDevice System, Imaging, Tympanic Membrane And Middle Ear2Product Code
- QQEImage Management Software For Planning Of Otologic And Neurotologic Procedures2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
StimSite
- Page Type
- Cleared 510(K)
- 510(k) Number
- K200886
- 510(k) Type
- Traditional
- Applicant
- Allotrope Medical Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/10/2020
- Days to Decision
- 222 days
- Submission Type
- Summary