Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- 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
- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Neurological Surgical DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- NGUBalloon, Liver Tamponade2Product Code
- EYRTourniquet, Gastro-Urology1Product Code
- EXMTruss, Umbilical1Product Code
- EYNTray, Irrigation, Sterile2Product Code
- FBQTrocar, Gastro-Urology2Product Code
- FZGApparatus, Air Handling, Bench2Product Code
- FZHApparatus, Air Handling, Room2Product Code
- FZIApparatus, Air Handling, Enclosure2Product Code
- GAXTourniquet, Nonpneumatic1Product Code
- KCWEpilator, High Frequency, Needle-Type1Product Code
- KCXEpilator, High Frequency, Tweezer-Type1Product Code
- KCYTourniquet, Pneumatic1Product Code
- K202919ATS 5000 Automatic Tourniquet Instrument1Cleared 510(K)
- K162365T-Cuff1Cleared 510(K)
- K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM1Cleared 510(K)
- K112874EZ VEIN INFLATABLE TOURNIQUET1Cleared 510(K)
- K071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C0700021Cleared 510(K)
- K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM1Cleared 510(K)
- K012632TOURNIQUET CUFF; PNEUMATIC TOURNIQUET1Cleared 510(K)
- K955552EXPRESSAIRE TORUNIQUET SYSTEM1Cleared 510(K)
- K954201BUONAFEDE PNEUMATIC SLEEVE1Cleared 510(K)
- K954103TOURNI-COMP1Cleared 510(K)
- K953953DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF1Cleared 510(K)
- K952038CLEAN-CUFF1Cleared 510(K)
- K940615ACCUTEST1Cleared 510(K)
- K945167DJ MEDICAL PNEUMATIC TOURNIQUET1Cleared 510(K)
- K942303TECNADYNE T-CUFF1Cleared 510(K)
- K933994ARTHREX TOURNIQUET FOR LEG HOLDER1Cleared 510(K)
- K925033STILLE AUTOMATIC TOURNIQUET1Cleared 510(K)
- K924273ACCUFLATE1Cleared 510(K)
- K910449PRESTITCH1Cleared 510(K)
- K910512ACCUFLATE1Cleared 510(K)
- K900104TCPM II TOURNIQUET CUFF PRESSURE MONITOR1Cleared 510(K)
- K890014DISPOSABLE COLOR-CUFFS1Cleared 510(K)
- K8800203 IN 1 AUTOMATIC TOURNIQUET1Cleared 510(K)
- K871982TOURNIQUET PRESSURE REGULATOR1Cleared 510(K)
- K870784A.T.S. 1500 TOURNIQUET1Cleared 510(K)
- K860463SINGLE AND DUAL TOURNIQUET CUFF1Cleared 510(K)
- K860095DIGIKIT NONPNEUMATIC TOURNIQUET1Cleared 510(K)
- K853802ATS 500 TOURNIQUET1Cleared 510(K)
- K842963RHYS-DAVIES EXSANGUINATOR1Cleared 510(K)
- K841558BANANA CUFF1Cleared 510(K)
- K840206PRESSURE SENTRY TOURNIQUET1Cleared 510(K)
- K813231TOURNIQUET1Cleared 510(K)
- K791759TEST PRESSURE GAUGE #6675-321Cleared 510(K)
- K780988DEVIN-NESTOR PNEUMATIC TOURNIQUET1Cleared 510(K)
- KPJChamber, Oxygen, Topical, Extremity2Product Code
- OJSTourniquet Kit1Product Code
- OLIFat Reducing Low Level Laser2Product Code
- PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use2Product Code
- QGXGeneral Use Pneumatic Tourniquet1Product Code
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
DIGIKIT NONPNEUMATIC TOURNIQUET
- Page Type
- Cleared 510(K)
- 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