Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- 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—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—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
- K931198UNIQUET1Cleared 510(K)
- K881398TOURNIQUET1Cleared 510(K)
- K881176STERILE ESMARCH BANDAGE1Cleared 510(K)
- K875092DEGANIA SILICONE TOURNIQUET1Cleared 510(K)
- K873928UNIVERSAL TOURNIQUET1Cleared 510(K)
- K872003KINDERWRAP1Cleared 510(K)
- K864897DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 13351Cleared 510(K)
- K853472FINGER TOURNIQUETTE1Cleared 510(K)
- K853537VELCRO TOURNIQUET1Cleared 510(K)
- K852277CATAPRESS TOURNIGUET1Cleared 510(K)
Show All 20 Submissions
- KCWEpilator, High Frequency, Needle-Type1Product Code
- KCXEpilator, High Frequency, Tweezer-Type1Product Code
- KCYTourniquet, Pneumatic1Product Code
- 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
UNIQUET
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K931198
- 510(k) Type
- Traditional
- Applicant
- ICAT SYSTEMS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/1/1993
- Days to Decision
- 176 days
- Submission Type
- Statement