Product code GAX
- Device name
- Tourniquet, Nonpneumatic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.5900
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931198 | UNIQUET | Icat Systems | 1993-09-01 |
| K881398 | TOURNIQUET | Barretta Products, Research and Development, Inc. | 1988-04-29 |
| K881176 | STERILE ESMARCH BANDAGE | Spectrum/Hydro-Med Products, Inc. | 1988-04-11 |
| K875092 | DEGANIA SILICONE TOURNIQUET | Degania Silicone , Ltd. | 1988-01-07 |
| K873928 | UNIVERSAL TOURNIQUET | Dryden Corp. | 1987-10-23 |
| K872003 | KINDERWRAP | The Kinder Co. | 1987-06-23 |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | Dale Medical Products, Inc. | 1987-01-12 |
| K853472 | FINGER TOURNIQUETTE | Joseph B. Marogil | 1985-10-10 |
| K853537 | VELCRO TOURNIQUET | Cp Medical | 1985-09-12 |
| K852277 | CATAPRESS TOURNIGUET | Boehringer Ingelheim Pharmaceuticals, Inc. | 1985-06-27 |
| K851482 | TOURNIQUET | Polymer Technology Corp. | 1985-04-29 |
| K843056 | ELASTIC BANDAGE | Sterile Medical Systems | 1984-12-04 |
| K840489 | DISPOSIQUET A DISPOS. TOURNIQUET | Med Lab Products | 1984-03-12 |
| K830467 | TOURNIQUET/LATEX TOURNIQUET | Primeline Industries, Inc. | 1983-03-31 |
| K822553 | PRESSURE-QUET TOURNIQUET | Nutec Med, Inc. | 1982-09-17 |
| K821700 | LATEX PENROSE DRAIN TUBING | Abco Dealers, Inc. | 1982-06-16 |
| K803142 | CONPHAR VELCRO TOUNIGUER | Conphar, Inc. | 1981-01-13 |
| K790802 | ESSAR TOURNIQUET FOR VENIPUNCTURE | Stewart Research, Inc. | 1979-05-01 |
| K780594 | VELKET TOURNIQUET | Abco Dealers, Inc. | 1978-06-06 |
| K780429 | TOURNEQUET, NON-PNEUMATIC | Hemox, Inc. | 1978-04-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10195327410186 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-05-21 |
| 10195327339951 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-02-12 |
| 10665973020652 | American White Cross | Dukal LLC | 2022-12-06 |
| 10665973020645 | American White Cross | Dukal LLC | 2022-12-06 |
| 10665973020638 | American White Cross | Dukal LLC | 2022-12-06 |
| 10665973020621 | American White Cross | Dukal LLC | 2022-12-06 |
| 10665973012725 | DawnMist | Dukal LLC | 2022-12-06 |
| 10665973012541 | DawnMist | Dukal LLC | 2022-12-06 |
| 10665973012534 | DawnMist | Dukal LLC | 2022-12-06 |
| 10665973012527 | DawnMist | Dukal LLC | 2022-12-06 |
| 10665973012510 | DawnMist | Dukal LLC | 2022-12-06 |
| 10665973012176 | DawnMist | Dukal LLC | 2022-12-06 |
| 10653160241621 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160281177 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| M36818061 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-09 |
| M36841091 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-09 |
| M368410911 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-09 |
| M36841091LF1 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-09 |
| 10612553014563 | ESMARK 4X12 ST 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553014532 | ESMARK 3X9 ST 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553014549 | ESMARK 3X12 ST 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553014556 | ESMARK 4X9 ST 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553014587 | ESMARK 6X12 ST 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553014570 | ESMARK 6X9 ST 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553017199 | NOVAPLUS ESMARK V1862 6X12 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553017182 | NOVAPLUS ESMARK V1861 6X9 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553017175 | NOVAPLUS ESMARK V1842 4X12 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553017168 | NOVAPLUS ESMARK V1841 4X9 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612553017144 | NOVAPLUS ESMARK V1831 3X9 20/CS | HARTMANN USA, INC. | 2020-09-01 |
| 10612479168944 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-05-28 |