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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
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
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Neurological Surgical 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
NGU
Balloon, Liver Tamponade
2
Product Code
EYR
Tourniquet, Gastro-Urology
1
Product Code
EXM
Truss, Umbilical
1
Product Code
EYN
Tray, Irrigation, Sterile
2
Product Code
FBQ
Trocar, Gastro-Urology
2
Product Code
FZG
Apparatus, Air Handling, Bench
2
Product Code
FZH
Apparatus, Air Handling, Room
2
Product Code
FZI
Apparatus, Air Handling, Enclosure
2
Product Code
GAX
Tourniquet, Nonpneumatic
1
Product Code
KCW
Epilator, High Frequency, Needle-Type
1
Product Code
KCX
Epilator, High Frequency, Tweezer-Type
1
Product Code
KCY
Tourniquet, Pneumatic
1
Product Code
K
20
2919
ATS 5000 Automatic Tourniquet Instrument
1
Cleared 510(K)
K
16
2365
T-Cuff
1
Cleared 510(K)
K
12
3553
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
1
Cleared 510(K)
K
11
2874
EZ VEIN INFLATABLE TOURNIQUET
1
Cleared 510(K)
K
07
1140
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
1
Cleared 510(K)
K
05
0411
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
1
Cleared 510(K)
K
01
2632
TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
1
Cleared 510(K)
K
95
5552
EXPRESSAIRE TORUNIQUET SYSTEM
1
Cleared 510(K)
K
95
4201
BUONAFEDE PNEUMATIC SLEEVE
1
Cleared 510(K)
K
95
4103
TOURNI-COMP
1
Cleared 510(K)
K
95
3953
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
1
Cleared 510(K)
K
95
2038
CLEAN-CUFF
1
Cleared 510(K)
K
94
0615
ACCUTEST
1
Cleared 510(K)
K
94
5167
DJ MEDICAL PNEUMATIC TOURNIQUET
1
Cleared 510(K)
K
94
2303
TECNADYNE T-CUFF
1
Cleared 510(K)
K
93
3994
ARTHREX TOURNIQUET FOR LEG HOLDER
1
Cleared 510(K)
K
92
5033
STILLE AUTOMATIC TOURNIQUET
1
Cleared 510(K)
K
92
4273
ACCUFLATE
1
Cleared 510(K)
K
91
0449
PRESTITCH
1
Cleared 510(K)
K
91
0512
ACCUFLATE
1
Cleared 510(K)
K
90
0104
TCPM II TOURNIQUET CUFF PRESSURE MONITOR
1
Cleared 510(K)
K
89
0014
DISPOSABLE COLOR-CUFFS
1
Cleared 510(K)
K
88
0020
3 IN 1 AUTOMATIC TOURNIQUET
1
Cleared 510(K)
K
87
1982
TOURNIQUET PRESSURE REGULATOR
1
Cleared 510(K)
K
87
0784
A.T.S. 1500 TOURNIQUET
1
Cleared 510(K)
K
86
0463
SINGLE AND DUAL TOURNIQUET CUFF
1
Cleared 510(K)
K
86
0095
DIGIKIT NONPNEUMATIC TOURNIQUET
1
Cleared 510(K)
K
85
3802
ATS 500 TOURNIQUET
1
Cleared 510(K)
K
84
2963
RHYS-DAVIES EXSANGUINATOR
1
Cleared 510(K)
K
84
1558
BANANA CUFF
1
Cleared 510(K)
K
84
0206
PRESSURE SENTRY TOURNIQUET
1
Cleared 510(K)
K
81
3231
TOURNIQUET
1
Cleared 510(K)
K
79
1759
TEST PRESSURE GAUGE #6675-32
1
Cleared 510(K)
K
78
0988
DEVIN-NESTOR PNEUMATIC TOURNIQUET
1
Cleared 510(K)
KPJ
Chamber, Oxygen, Topical, Extremity
2
Product Code
OJS
Tourniquet Kit
1
Product Code
OLI
Fat Reducing Low Level Laser
2
Product Code
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
2
Product Code
QGX
General Use Pneumatic Tourniquet
1
Product Code
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 26 May 2023 at 11:04 pm
SU
/
therapeutic-devices
/
KCY
/
K860095
View Source
DIGIKIT NONPNEUMATIC TOURNIQUET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K860095
510(k) Type
Traditional
Applicant
ORTHOFAB, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/24/1986
Days to Decision
14 days
FDA Browser
by
Innolitics
Anesthesiology
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
Diagnostic Devices
General Hospital and Personal Use Monitoring Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Neurological Surgical Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
NGU
Balloon, Liver Tamponade
EYR
Tourniquet, Gastro-Urology
EXM
Truss, Umbilical
EYN
Tray, Irrigation, Sterile
FBQ
Trocar, Gastro-Urology
FZG
Apparatus, Air Handling, Bench
FZH
Apparatus, Air Handling, Room
FZI
Apparatus, Air Handling, Enclosure
GAX
Tourniquet, Nonpneumatic
KCW
Epilator, High Frequency, Needle-Type
KCX
Epilator, High Frequency, Tweezer-Type
KCY
Tourniquet, Pneumatic
K
20
2919
ATS 5000 Automatic Tourniquet Instrument
K
16
2365
T-Cuff
K
12
3553
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K
11
2874
EZ VEIN INFLATABLE TOURNIQUET
K
07
1140
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
K
05
0411
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K
01
2632
TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
K
95
5552
EXPRESSAIRE TORUNIQUET SYSTEM
K
95
4201
BUONAFEDE PNEUMATIC SLEEVE
K
95
4103
TOURNI-COMP
K
95
3953
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
K
95
2038
CLEAN-CUFF
K
94
0615
ACCUTEST
K
94
5167
DJ MEDICAL PNEUMATIC TOURNIQUET
K
94
2303
TECNADYNE T-CUFF
K
93
3994
ARTHREX TOURNIQUET FOR LEG HOLDER
K
92
5033
STILLE AUTOMATIC TOURNIQUET
K
92
4273
ACCUFLATE
K
91
0449
PRESTITCH
K
91
0512
ACCUFLATE
K
90
0104
TCPM II TOURNIQUET CUFF PRESSURE MONITOR
K
89
0014
DISPOSABLE COLOR-CUFFS
K
88
0020
3 IN 1 AUTOMATIC TOURNIQUET
K
87
1982
TOURNIQUET PRESSURE REGULATOR
K
87
0784
A.T.S. 1500 TOURNIQUET
K
86
0463
SINGLE AND DUAL TOURNIQUET CUFF
K
86
0095
DIGIKIT NONPNEUMATIC TOURNIQUET
K
85
3802
ATS 500 TOURNIQUET
K
84
2963
RHYS-DAVIES EXSANGUINATOR
K
84
1558
BANANA CUFF
K
84
0206
PRESSURE SENTRY TOURNIQUET
K
81
3231
TOURNIQUET
K
79
1759
TEST PRESSURE GAUGE #6675-32
K
78
0988
DEVIN-NESTOR PNEUMATIC TOURNIQUET
KPJ
Chamber, Oxygen, Topical, Extremity
OJS
Tourniquet Kit
OLI
Fat Reducing Low Level Laser
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
QGX
General Use Pneumatic Tourniquet
Toxicology
Medical Genetics
Unknown
SU
/
therapeutic-devices
/
KCY
/
K860095
View Source
DIGIKIT NONPNEUMATIC TOURNIQUET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K860095
510(k) Type
Traditional
Applicant
ORTHOFAB, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/24/1986
Days to Decision
14 days