FFGClass II
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
21 CFR 876.1800 / Gastroenterology, Urology
FFG is the FDA product code for Device, Urine Flow Rate Measuring, Non-Electrical, Disposable, a class II device type, regulated under 21 CFR 876.1800. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- FFG
- Device name
- Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Regulation
- 21 CFR 876.1800
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 17
- Ingested recalls
- 1
Clearances, product code FFG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 3 |
| 1981 | 2 |
| 1982 | 1 |
| 1984 | 3 |
| 1985 | 4 |
| 1989 | 2 |
Applicants with the most clearances
Product code FFG| Applicant | Clearances |
|---|---|
| Vital Metrics, Inc. | 3 |
| Browne Medical, Inc. | 1 |
| Burron Medical Products, Inc. | 1 |
| C.R. Bard Inc | 1 |
| Epcom Medical Systems, Inc. | 1 |
| Eris Medical Technology | 1 |
| Hewlett-Packard Co. | 1 |
| Joseph F. Daniel, C.R.N.A. | 1 |
| Kendall Research Center | 1 |
| Laytech Medical Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Amsino Medical (Kunshan) Co., Ltd.
- Amsino Medical (Shanghai) Co., Ltd.
- Anhui Careplus Medical Technology Co., Ltd.
- Anji Spenq Industrial Co., Ltd.
- Biotronix Healthcare Industries Inc.
- Boen Healthcare Co., Ltd.
- C.R. Bard Inc
- Cardinal Health (Kenmex Medical Specialties)
- Changshu Rozer Sterilization Technology Co., Ltd.
- Conod Medical Co., Ltd.
- Conod Medical Shuyang Co., Ltd.
- ConvaTec Limited
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.
