Degania Silicone Tourniquet
FDA 510(k) K875092 · Degania Silicone , Ltd.
510(k) numberK875092
Submission
- Device name
- Degania Silicone Tourniquet
- Applicant
- Degania Silicone , Ltd.
Emek Hayarden, IL - Received
- December 10, 1987
- Decision date
- January 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAX – Tourniquet, Nonpneumatic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.5900
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GAX
| 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 |
| 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 |
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| K143378 | AQUARIUS Gastrostomy Replacement TubeKNT · Special | 12/29/2014SE |
| K141753 | Aquarius Nasal Feeding TubePIF · Traditional | 10/16/2014SE |
| K141631 | Aquarius Extension Feeding SetKNT · Special | 07/28/2014SESK |
| K132686 | Aquarius Low Profile Gastrostomy Feeding TubeKNT · Traditional | 05/12/2014SESK |
| K131020 | Temperature Sensor CatheterEZL · Special | 05/09/2013SE |
| K122030 | Low Profile Gastrostomy Feeding Tube or Gastrotomey ButtonKNT · Traditional | 09/05/2012SE |
| K103371 | Coude/ or TiemannEZL · Traditional | 03/11/2011SE |
Questions and answers
When was Degania Silicone Tourniquet cleared by the FDA?
Degania Silicone Tourniquet (K875092) received a 510(k) decision of Substantially Equivalent on January 7, 1988, 28 days after the submission was received.
What is the product code of K875092?
The FDA product code is GAX – Tourniquet, Nonpneumatic, a Class I (low risk) device regulated under 21 CFR 878.5900.