GAX
20 FDA 510(k) clearances · Product code
28 daysmedian time to decision
123 days90th percentile
20clearances measured
FDA profile
- Official device name
- Tourniquet, Nonpneumatic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.5900
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2002: 1 · 2003: 2 · 2007: 2 · 2008: 3 · 2010: 4 · 2011: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| UNIQUET (K931198) | Icat Systems | 1993-09-01 |
| TOURNIQUET (K881398) | Barretta Products, Research and Development, Inc. | 1988-04-29 |
| STERILE ESMARCH BANDAGE (K881176) | Spectrum/Hydro-Med Products, Inc. | 1988-04-11 |
| DEGANIA SILICONE TOURNIQUET (K875092) | Degania Silicone , Ltd. | 1988-01-07 |
| UNIVERSAL TOURNIQUET (K873928) | Dryden Corp. | 1987-10-23 |
| KINDERWRAP (K872003) | The Kinder Co. | 1987-06-23 |
| DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (K864897) | Dale Medical Products, Inc. | 1987-01-12 |
| FINGER TOURNIQUETTE (K853472) | Joseph B. Marogil | 1985-10-10 |
| VELCRO TOURNIQUET (K853537) | Cp Medical | 1985-09-12 |
| CATAPRESS TOURNIGUET (K852277) | Boehringer Ingelheim Pharmaceuticals, Inc. | 1985-06-27 |
| TOURNIQUET (K851482) | Polymer Technology Corp. | 1985-04-29 |
| ELASTIC BANDAGE (K843056) | Sterile Medical Systems | 1984-12-04 |
| DISPOSIQUET A DISPOS. TOURNIQUET (K840489) | Med Lab Products | 1984-03-12 |
| TOURNIQUET/LATEX TOURNIQUET (K830467) | Primeline Industries, Inc. | 1983-03-31 |
| PRESSURE-QUET TOURNIQUET (K822553) | Nutec Med, Inc. | 1982-09-17 |
| LATEX PENROSE DRAIN TUBING (K821700) | Abco Dealers, Inc. | 1982-06-16 |
| CONPHAR VELCRO TOUNIGUER (K803142) | Conphar, Inc. | 1981-01-13 |
| ESSAR TOURNIQUET FOR VENIPUNCTURE (K790802) | Stewart Research, Inc. | 1979-05-01 |
| VELKET TOURNIQUET (K780594) | Abco Dealers, Inc. | 1978-06-06 |
| TOURNEQUET, NON-PNEUMATIC (K780429) | Hemox, Inc. | 1978-04-18 |
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