EYRClass I
Tourniquet, Gastro-Urology
21 CFR 878.5900 / General, Plastic Surgery
EYR is the FDA product code for Tourniquet, Gastro-Urology, a class I device type, regulated under 21 CFR 878.5900. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- EYR
- Device name
- Tourniquet, Gastro-Urology
- Regulation
- 21 CFR 878.5900
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code EYR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 1 |
Applicants with the most clearances
Product code EYR| Applicant | Clearances |
|---|---|
| Keithley Development Co. | 1 |
| Tecnol New Jersey Wound Care, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Ambler Surgical, LLC
- Aspen Surgical Products, Inc.
- Boss Instruments, Ltd.
- Falcon Surgical Co. (Pvt.) Ltd.
- Finix Industrial Co., Ltd.
- Hangzhou Rollmed Co.,Ltd.
- Heuer International (A division of GST Corporation Limited)
- Industrias Apson S.A de C.V
- Instrumed International Inc dba Avalign German Specialty Instruments
- Integra LifeSciences Corporation
- Integra LifeSciences Production Corporation
- Jarit GmbH
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
