GAX · Tourniquet, Nonpneumatic
General, Plastic Surgery · 21 CFR 878.5900 · Class 1
Overview
| Product Code | GAX |
|---|---|
| Device Name | Tourniquet, Nonpneumatic |
| Regulation | 21 CFR 878.5900 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931198 | UNIQUET | Icat Systems | Sep 1, 1993 | SESE |
| K881398 | TOURNIQUET | Barretta Products, Research and Development, Inc. | Apr 29, 1988 | SESE |
| K881176 | STERILE ESMARCH BANDAGE | Spectrum/Hydro-Med Products, Inc. | Apr 11, 1988 | SESE |
| K875092 | DEGANIA SILICONE TOURNIQUET | Degania Silicone , Ltd. | Jan 7, 1988 | SESE |
| K873928 | UNIVERSAL TOURNIQUET | Dryden Corp. | Oct 23, 1987 | SESE |
| K872003 | KINDERWRAP | The Kinder Co. | Jun 23, 1987 | SESE |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | Dale Medical Products, Inc. | Jan 12, 1987 | SESE |
| K853472 | FINGER TOURNIQUETTE | Joseph B. Marogil | Oct 10, 1985 | SESE |
| K853537 | VELCRO TOURNIQUET | Cp Medical | Sep 12, 1985 | SESE |
| K852277 | CATAPRESS TOURNIGUET | Boehringer Ingelheim Pharmaceuticals, Inc. | Jun 27, 1985 | SESE |
| K851482 | TOURNIQUET | Polymer Technology Corp. | Apr 29, 1985 | SESE |
| K843056 | ELASTIC BANDAGE | Sterile Medical Systems | Dec 4, 1984 | SESE |
| K840489 | DISPOSIQUET A DISPOS. TOURNIQUET | Med Lab Products | Mar 12, 1984 | SESE |
| K830467 | TOURNIQUET/LATEX TOURNIQUET | Primeline Industries, Inc. | Mar 31, 1983 | SESE |
| K822553 | PRESSURE-QUET TOURNIQUET | Nutec Med, Inc. | Sep 17, 1982 | SESE |
| K821700 | LATEX PENROSE DRAIN TUBING | Abco Dealers, Inc. | Jun 16, 1982 | SESE |
| K803142 | CONPHAR VELCRO TOUNIGUER | Conphar, Inc. | Jan 13, 1981 | SESE |
| K790802 | ESSAR TOURNIQUET FOR VENIPUNCTURE | Stewart Research, Inc. | May 1, 1979 | SESE |
| K780594 | VELKET TOURNIQUET | Abco Dealers, Inc. | Jun 6, 1978 | SESE |
| K780429 | TOURNEQUET, NON-PNEUMATIC | Hemox, Inc. | Apr 18, 1978 | SESE |
Top Applicants
- Abco Dealers, Inc. — 2 clearances
- The Kinder Co. — 1 clearance
- Stewart Research, Inc. — 1 clearance
- Sterile Medical Systems — 1 clearance
- Spectrum/Hydro-Med Products, Inc. — 1 clearance
