Tourniquet, Nonpneumatic
FDA product code GAX · Class I (low risk) · 21 CFR 878.5900 · General, Plastic Surgery
20510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Abco Dealers, Inc. 2
- Icat Systems 1
- Hemox, Inc. 1
- Barretta Products, Research and Development, Inc. 1
- Spectrum/Hydro-Med Products, Inc. 1
- Degania Silicone, Ltd. 1
- Dryden Corp. 1
- The Kinder Co. 1
- Dale Medical Products, Inc. 1
- Joseph B. Marogil 1
- Cp Medical 1
- Boehringer Ingelheim Pharmaceuticals, Inc. 1
- Polymer Technology Corp. 1
- Sterile Medical Systems 1
- Med Lab Products 1
- Primeline Industries, Inc. 1
- Nutec Med, Inc. 1
- Conphar, Inc. 1
- Stewart Research, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931198 | UniquetGAX · Traditional | Icat Systems | 09/01/1993SE |
| K881398 | TourniquetGAX · Traditional | Barretta Products, Research and Development, Inc. | 04/29/1988SE |
| K881176 | Sterile Esmarch BandageGAX · Traditional | Spectrum/Hydro-Med Products, Inc. | 04/11/1988SE |
| K875092 | Degania Silicone TourniquetGAX · Traditional | Degania Silicone , Ltd. | 01/07/1988SE |
| K873928 | Universal TourniquetGAX · Traditional | Dryden Corp. | 10/23/1987SE |
| K872003 | KinderwrapGAX · Traditional | The Kinder Co. | 06/23/1987SE |
| K864897 | Dale Venipuncture Tourniquet, Product No. 1335GAX · Traditional | Dale Medical Products, Inc. | 01/12/1987SE |
| K853472 | Finger TourniquetteGAX · Traditional | Joseph B. Marogil | 10/10/1985SE |
| K853537 | Velcro TourniquetGAX · Traditional | Cp Medical | 09/12/1985SE |
| K852277 | Catapress TourniguetGAX · Traditional | Boehringer Ingelheim Pharmaceuticals, Inc. | 06/27/1985SE |
| K851482 | TourniquetGAX · Traditional | Polymer Technology Corp. | 04/29/1985SE |
| K843056 | Elastic BandageGAX · Traditional | Sterile Medical Systems | 12/04/1984SE |
| K840489 | Disposiquet a Dispos. TourniquetGAX · Traditional | Med Lab Products | 03/12/1984SE |
| K830467 | Tourniquet/Latex TourniquetGAX · Traditional | Primeline Industries, Inc. | 03/31/1983SE |
| K822553 | Pressure-Quet TourniquetGAX · Traditional | Nutec Med, Inc. | 09/17/1982SE |
| K821700 | Latex Penrose Drain TubingGAX · Traditional | Abco Dealers, Inc. | 06/16/1982SE |
| K803142 | Conphar Velcro TouniguerGAX · Traditional | Conphar, Inc. | 01/13/1981SE |
| K790802 | Essar Tourniquet for VenipunctureGAX · Traditional | Stewart Research, Inc. | 05/01/1979SE |
| K780594 | Velket TourniquetGAX · Traditional | Abco Dealers, Inc. | 06/06/1978SE |
| K780429 | Tournequet, Non-PneumaticGAX · Traditional | Hemox, Inc. | 04/18/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0945-2021 Class II | Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet -…A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on… | Mar-Med Co | 12/28/2020Terminated |
| Z-2228-2018 Class II | Part #: SAM XT-C, Model: Hi-Viz BlueBased on internal testing, results indicated a possible failure of the stitches securing the buckle to the… | The Seaberg Company Inc | 05/02/2018Terminated |
| Z-2227-2018 Class II | Part #: SAM XT-C, Model: Hi-Viz Orange or CivilianBased on internal testing, results indicated a possible failure of the stitches securing the buckle to the… | The Seaberg Company Inc | 05/02/2018Terminated |
| Z-2226-2018 Class II | Part #: SAM XT-M, Model: Tactical Black or MilitaryBased on internal testing, results indicated a possible failure of the stitches securing the buckle to the… | The Seaberg Company Inc | 05/02/2018Terminated |
| Z-0228-2016 Class II | MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet…Once tested, it is required that the tourniquet be returned to its Ready position then placed in its… | Pyng Medical Corporation | 08/31/2015Terminated |
| Z-2295-2014 Class II | Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes…ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may… | ICU Medical, Inc. | 08/05/2014Terminated |
| Z-2294-2014 Class II | Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes…ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may… | ICU Medical, Inc. | 08/05/2014Terminated |
| Z-2293-2014 Class II | CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged…ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may… | ICU Medical, Inc. | 08/05/2014Terminated |