Sterile Esmarch Bandage
FDA 510(k) K881176 · Spectrum/Hydro-Med Products, Inc.
510(k) numberK881176
Submission
- Device name
- Sterile Esmarch Bandage
- Applicant
- Spectrum/Hydro-Med Products, Inc.
Dallas, TX, US - Received
- March 18, 1988
- Decision date
- April 11, 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 |
| 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 |
Questions and answers
When was Sterile Esmarch Bandage cleared by the FDA?
Sterile Esmarch Bandage (K881176) received a 510(k) decision of Substantially Equivalent on April 11, 1988, 24 days after the submission was received.
What is the product code of K881176?
The FDA product code is GAX – Tourniquet, Nonpneumatic, a Class I (low risk) device regulated under 21 CFR 878.5900.