FFDClass I
Evacuator, Bladder, Manually Operated
21 CFR 876.4370 / Gastroenterology, Urology
FFD is the FDA product code for Evacuator, Bladder, Manually Operated, a class I device type, regulated under 21 CFR 876.4370. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FFD
- Device name
- Evacuator, Bladder, Manually Operated
- Regulation
- 21 CFR 876.4370
- Device class
- Class I
- 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
- 2
- Ingested recalls
- 0
Clearances, product code FFD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1987 | 1 |
Applicants with the most clearances
Product code FFD| Applicant | Clearances |
|---|---|
| Cumes-Honikman Partnership | 1 |
| V. Mueller O.V. Baxter Healthcare Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Ace Medical Devices Pvt. Ltd
- Aesculap Inc
- Allwin Medical Devices, Inc.
- American Medical Endoscopy
- Amnotec International Medical GmbH
- Aspen Surgical Products, Inc.
- Boston Scientific Corporation
- CALYX MEDICAL Sp. Z.O.O.
- Centre de distribution Coloplast le Plessis Pate
- Changshu Rozer Sterilization Technology Co., Ltd.
- Coloplast Manufacturing France, SAS
- 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.
