FDA product code BYZ: Trap, Sterile Specimen
BYZ is the FDA product code for trap, sterile specimen. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. FDA has cleared 9 510(k) submissions under BYZ, from 8 different applicants. The average 510(k) review took 55 days (median 57). FDA has posted 1 recall for BYZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Trap, Sterile Specimen |
| Device class | Class II |
| Regulation | 21 CFR 880.6740 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYZ clearance
Top BYZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bemis Health Care | 2 | 1982-10-18 |
| Electromedics, Inc. | 1 | 1993-02-05 |
| Medical Device Inspection Co., Inc. | 1 | 1991-10-10 |
| Triton Technology, Inc. | 1 | 1990-09-12 |
| Warne Surgical Products, Ltd. | 1 | 1984-04-18 |
3 more applicants have BYZ clearances. See the full list in Caduvo.
Most recent BYZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925412 | Electromedics, Inc. | ELECTROMEDICS TISSUE TRAP/ #TT280 | 1993-02-05 | 102 |
| K913643 | Medical Device Inspection Co., Inc. | MUCOUS SPECIMEN TRAP | 1991-10-10 | 57 |
| K902883 | Triton Technology, Inc. | TISSUE/POLYP TRAP SYSTEM | 1990-09-12 | 72 |
| K841409 | Warne Surgical Products, Ltd. | BUSH NECK W/PLUG | 1984-04-18 | 13 |
| K840253 | Delta Medical Industries | ONE-WAY AIR VALVE | 1984-04-05 | 73 |
Recalls for BYZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-11-04.
Frequently asked questions
What is FDA product code BYZ?
BYZ is the FDA product code for trap, sterile specimen. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is BYZ?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYZ?
Across 9 cleared submissions the average was 55 days from receipt to decision (median 57).
Which companies have the most BYZ clearances?
Bemis Health Care (2); Electromedics, Inc. (1); Medical Device Inspection Co., Inc. (1); Triton Technology, Inc. (1); Warne Surgical Products, Ltd. (1).
Have BYZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-11-04.
Next steps
- Run an FDA pathway report with predicate devices for product code BYZ
- Run a recall and safety report across every BYZ manufacturer
- Watch product code BYZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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