FDA product code EZB: Stylet For Catheter, Gastro-Urology
EZB is the FDA product code for stylet for catheter, gastro-urology. It is a Class I device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under EZB, from 3 different applicants. The average 510(k) review took 24 days (median 10). FDA has posted 13 recalls for EZB devices.
Classification
| Field | Value |
|---|---|
| Device name | Stylet For Catheter, Gastro-Urology |
| Device class | Class I |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EZB clearance
Top EZB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Medical Resources | 1 | 1997-05-05 |
| Lake Region Mfg., Inc. | 1 | 1997-03-25 |
| Endovations | 1 | 1987-12-07 |
Most recent EZB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971498 | Applied Medical Resources | APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE | 1997-05-05 | 10 |
| K970994 | Lake Region Mfg., Inc. | CORE AND COIL ASSEMBLY GUIDEWIRE | 1997-03-25 | 6 |
| K874164 | Endovations | GUIDE WIRE | 1987-12-07 | 55 |
Recalls for EZB devices
13 product recalls in 2 recall events; 0 initiated in the last five years and 12 still open. Most recent: 2020-03-09.
| Year | Recalls |
|---|---|
| 2020 | 12 |
Frequently asked questions
What is FDA product code EZB?
EZB is the FDA product code for stylet for catheter, gastro-urology. It is a Class I device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is EZB?
Class I, regulation 21 CFR 876.5130. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EZB?
Across 3 cleared submissions the average was 24 days from receipt to decision (median 10).
Which companies have the most EZB clearances?
Applied Medical Resources (1); Lake Region Mfg., Inc. (1); Endovations (1).
Have EZB devices been recalled?
Yes: 13 product recalls across 2 recall events; the most recent began 2020-03-09.
Next steps
- Run an FDA pathway report with predicate devices for product code EZB
- Run a recall and safety report across every EZB manufacturer
- Watch product code EZB 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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