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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular Diagnostic Devices
CFR Sub-Part
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Therapeutic Devices
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
CFR Sub-Part
BRX
Stool, Anesthesia
1
Product Code
BRY
Cabinet, Table And Tray, Anesthesia
1
Product Code
BSY
Catheters, Suction, Tracheobronchial
1
Product Code
BTI
Compressor, Air, Portable
2
Product Code
BXJ
Clip, Nose
1
Product Code
BXK
Gas, Calibration (Specified Concentration)
1
Product Code
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
1
Product Code
CAM
Yoke Assembly, Medical Gas
1
Product Code
CCX
Support, Patient Position
1
Product Code
K
94
3837
CHIN UP
1
Cleared 510(K)
K
93
2305
VILA-COOKE(TM) ANESTHESIA PILLOW
1
Cleared 510(K)
K
93
4235
SNIFF POSITION PILLOW
1
Cleared 510(K)
K
86
1915
SURGICAL HEAD SUPPORT
1
Cleared 510(K)
K
83
3022
AIR UTERINE DISPLACER-AUD 120
1
Cleared 510(K)
K
82
1838
VARI-SUPPORT LOW BACK POSTURE PILLOW
1
Cleared 510(K)
K
81
0035
PRENATAL SUPPORT PILLOW
1
Cleared 510(K)
K
80
1330
ANSPACH LEG SUPPORT
1
Cleared 510(K)
OFO
Airway Suction Kit
1
Product Code
OFR
Tracheobronchial Suction Catheter Kit
1
Product Code
OFS
Tracheal Suction Set
1
Product Code
OYI
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
1
Product Code
BSD
Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling
3
Product Code
LSZ
Ventilator, High Frequency
3
Product Code
LYM
Device, Cpr Assist
U
Product Code
MNQ
Stimulator, Hypoglossal Nerve, Implanted, Apnea
3
Product Code
NJK
Valve, Pulmonary
3
Product Code
OAZ
One-Way Air-Leak Valve
F
Product Code
OIR
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
F
Product Code
OOY
Bronchial Thermoplasty System
3
Product Code
PDR
Computer-Assisted Personalized Sedation System
3
Product Code
PNC
Catheter Introducer
N
Product Code
POI
Lung Tissue Sealant For Lung Volume Reduction
N
Product Code
PSR
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
3
Product Code
QGZ
Electrical Tumor Treatment Fields
3
Product Code
QKS
Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led
N
Product Code
QLI
Vaporizer, Cder Or Cber Led
N
Product Code
QOQ
Non-Continuous Ventilator For Emergency Use
N
Product Code
QOR
Continuous Ventilator, Minimal Ventilatory Support
N
Product Code
QOU
Emergency Resuscitator
N
Product Code
QOW
Ventilatory Assistance Helmet
N
Product Code
QPR
Neurological Stimulation For Emergency Use
N
Product Code
QRS
Device For Sleep Apnea Testing Based On Mandibular Movement
2
Product Code
QSF
Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
3
Product Code
Submissions with No Product Code
Miscellaneous
Monitoring Devices
CFR Sub-Part
Neurological Therapeutic Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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 26 May 2023 at 11:04 pm
AN
/
miscellaneous
/
CCX
/
K861915
View Source
SURGICAL HEAD SUPPORT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K861915
510(k) Type
Traditional
Applicant
TREACE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/30/1986
Days to Decision
11 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular Diagnostic Devices
Cardiovascular Monitoring Devices
Cardiovascular Therapeutic Devices
Diagnostic Devices
Miscellaneous
BRX
Stool, Anesthesia
BRY
Cabinet, Table And Tray, Anesthesia
BSY
Catheters, Suction, Tracheobronchial
BTI
Compressor, Air, Portable
BXJ
Clip, Nose
BXK
Gas, Calibration (Specified Concentration)
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
CAM
Yoke Assembly, Medical Gas
CCX
Support, Patient Position
K
94
3837
CHIN UP
K
93
2305
VILA-COOKE(TM) ANESTHESIA PILLOW
K
93
4235
SNIFF POSITION PILLOW
K
86
1915
SURGICAL HEAD SUPPORT
K
83
3022
AIR UTERINE DISPLACER-AUD 120
K
82
1838
VARI-SUPPORT LOW BACK POSTURE PILLOW
K
81
0035
PRENATAL SUPPORT PILLOW
K
80
1330
ANSPACH LEG SUPPORT
OFO
Airway Suction Kit
OFR
Tracheobronchial Suction Catheter Kit
OFS
Tracheal Suction Set
OYI
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
BSD
Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling
LSZ
Ventilator, High Frequency
LYM
Device, Cpr Assist
MNQ
Stimulator, Hypoglossal Nerve, Implanted, Apnea
NJK
Valve, Pulmonary
OAZ
One-Way Air-Leak Valve
OIR
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
OOY
Bronchial Thermoplasty System
PDR
Computer-Assisted Personalized Sedation System
PNC
Catheter Introducer
POI
Lung Tissue Sealant For Lung Volume Reduction
PSR
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
QGZ
Electrical Tumor Treatment Fields
QKS
Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led
QLI
Vaporizer, Cder Or Cber Led
QOQ
Non-Continuous Ventilator For Emergency Use
QOR
Continuous Ventilator, Minimal Ventilatory Support
QOU
Emergency Resuscitator
QOW
Ventilatory Assistance Helmet
QPR
Neurological Stimulation For Emergency Use
QRS
Device For Sleep Apnea Testing Based On Mandibular Movement
QSF
Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
Submissions with No Product Code
Monitoring Devices
Neurological Therapeutic Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
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
AN
/
miscellaneous
/
CCX
/
K861915
View Source
SURGICAL HEAD SUPPORT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K861915
510(k) Type
Traditional
Applicant
TREACE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/30/1986
Days to Decision
11 days