TOURNIQUET CUFF; PNEUMATIC TOURNIQUET— 510(k) K012632
Substantially EquivalentMedical Instruments Technology, Inc.
FDA 510(k) clearance K012632 for TOURNIQUET CUFF; PNEUMATIC TOURNIQUET, Substantially Equivalent on 2001-10-26. Applicant: Medical Instruments Technology, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical Instruments Technology, Inc.
- Product code
- Code KCY
- Device class
- Class 1
- Regulation
- 21 CFR 878.5910
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. George, UT, US
Recent devices under product code KCY
view allMore clearances from Medical Instruments Technology, Inc.
view all- K012614 — KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN
- K012640 — ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
- K012624 — REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS
- K884611 — THE ORTHORANGER II ELECTRONIC GONIOMETER
Adverse events under product code KCY
product code KCY- Malfunction
- 868
- Total
- 868
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.