BYZClass II
Trap, Sterile Specimen
21 CFR 880.6740 / General Hospital
BYZ is the FDA product code for Trap, Sterile Specimen, a class II device type, regulated under 21 CFR 880.6740. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- BYZ
- Device name
- Trap, Sterile Specimen
- Regulation
- 21 CFR 880.6740
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 9
- Ingested recalls
- 1
Clearances, product code BYZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1982 | 2 |
| 1984 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 1 |
Applicants with the most clearances
Product code BYZ| Applicant | Clearances |
|---|---|
| Bemis Health Care | 2 |
| Delta Medical Industries | 1 |
| Electromedics, Inc. | 1 |
| Medical Device Inspection Company | 1 |
| Medical Marketing Group | 1 |
| Microvasive | 1 |
| Triton Technology, Inc. | 1 |
| Warne Surgical Products, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Amsino Medical (Kunshan) Co., Ltd.
- Boen Healthcare Co., Ltd.
- Busse Hospital Disposables
- Canadian Hospital Specialties Ltd.
- CGN Huaray Technology Co., Ltd. Suzhou Branch
- Changzhou Endoclean Medical Device Co., Ltd.
- Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
- Changzhou Jiuhong Medical Instrument Co., Ltd.
- Coba Biomedical Pty (Ltd)
- Customed, Inc
- DeRoyal Industries, Inc.
- Gcmedica Enterprise Ltd. (Wuxi)
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.
