FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
ETK
Tube, Toynbee Diagnostic
1
Product Code
ETM
Gustometer, Sterile
1
Product Code
ETN
Stimulator, Nerve
2
Product Code
K
24
1917
EARP Nerve Cuff Electrode
2
Cleared 510(K)
K
23
2888
Disposable Laryngeal Electrodes
2
Cleared 510(K)
K
23
0320
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
2
Cleared 510(K)
K
23
0853
EARP Nerve Cuff Electrode
2
Cleared 510(K)
K
23
1580
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
2
Cleared 510(K)
K
22
3254
C2 Xplore
2
Cleared 510(K)
K
21
2164
Mapping Suction Probe
2
Cleared 510(K)
K
21
3246
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
2
Cleared 510(K)
K
21
2355
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
2
Cleared 510(K)
K
20
0886
StimSite
2
Cleared 510(K)
Show All 93 Submissions
ETP
Stimulator, Caloric-Water
1
Product Code
ETR
Adaptor, Short Increment Sensitivity Index (Sisi)
1
Product Code
ETS
Generator, Electronic Noise (For Audiometric Testing)
2
Product Code
ETT
Cushion, Earphone (For Audiometric Testing)
1
Product Code
ETY
Tester, Auditory Impedance
2
Product Code
EWA
Set, Audiometer Calibration
1
Product Code
EWC
Chamber, Acoustic (For Audiometric Testing)
1
Product Code
EWO
Audiometer
2
Product Code
KHH
Stimulator, Caloric-Air
1
Product Code
KLX
Electroglottograph
2
Product Code
LYN
Apparatus, Visual Reinforcement Audiometric
2
Product Code
NAS
Tympanometer
2
Product Code
NNJ
Gustometer, Non-Sterile
1
Product Code
NRK
Kit, Test, Olfactory
2
Product Code
PTO
Tester, Auditory Impedance, Exempt
2
Product Code
PTP
Tympanometer, Exempt
2
Product Code
LWI
Ultrasound, Sinus
2
Product Code
PSV
Ultrasound Bronchoscope
2
Product Code
QJG
Device System, Imaging, Tympanic Membrane And Middle Ear
2
Product Code
QQE
Image Management Software For Planning Of Otologic And Neurotologic Procedures
2
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
EN
/
subpart-b—diagnostic-devices
/
ETN
/
K212164
View Source
Mapping Suction Probe
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212164
510(k) Type
Traditional
Applicant
inomed Medizintechnik GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/11/2022
Days to Decision
487 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
ETK
Tube, Toynbee Diagnostic
ETM
Gustometer, Sterile
ETN
Stimulator, Nerve
K
24
1917
EARP Nerve Cuff Electrode
K
23
2888
Disposable Laryngeal Electrodes
K
23
0320
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
K
23
0853
EARP Nerve Cuff Electrode
K
23
1580
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K
22
3254
C2 Xplore
K
21
2164
Mapping Suction Probe
K
21
3246
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
K
21
2355
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
K
20
0886
StimSite
Show All 93 Submissions
ETP
Stimulator, Caloric-Water
ETR
Adaptor, Short Increment Sensitivity Index (Sisi)
ETS
Generator, Electronic Noise (For Audiometric Testing)
ETT
Cushion, Earphone (For Audiometric Testing)
ETY
Tester, Auditory Impedance
EWA
Set, Audiometer Calibration
EWC
Chamber, Acoustic (For Audiometric Testing)
EWO
Audiometer
KHH
Stimulator, Caloric-Air
KLX
Electroglottograph
LYN
Apparatus, Visual Reinforcement Audiometric
NAS
Tympanometer
NNJ
Gustometer, Non-Sterile
NRK
Kit, Test, Olfactory
PTO
Tester, Auditory Impedance, Exempt
PTP
Tympanometer, Exempt
LWI
Ultrasound, Sinus
PSV
Ultrasound Bronchoscope
QJG
Device System, Imaging, Tympanic Membrane And Middle Ear
QQE
Image Management Software For Planning Of Otologic And Neurotologic Procedures
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
subpart-b—diagnostic-devices
/
ETN
/
K212164
View Source
Mapping Suction Probe
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212164
510(k) Type
Traditional
Applicant
inomed Medizintechnik GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/11/2022
Days to Decision
487 days
Submission Type
Summary