FDA product code EZO: Urethrotome
EZO is the FDA product code for urethrotome. It is a Class II device, regulated under 21 CFR 876.4770 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under EZO, from 4 different applicants. The average 510(k) review took 267 days (median 102). FDA has posted 1 recall for EZO devices.
Classification
| Field | Value |
|---|---|
| Device name | Urethrotome |
| Device class | Class II |
| Regulation | 21 CFR 876.4770 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EZO clearance
Top EZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 2 | 1995-02-13 |
| Richard Wolf Medical Instruments Corp. | 1 | 2000-05-12 |
| Olympus America, Inc. | 1 | 1996-12-11 |
| Olympus Corp. | 1 | 1992-01-07 |
Most recent EZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000905 | Richard Wolf Medical Instruments Corp. | URETHROTOME 8667.XXX AND 8670.XXX | 2000-05-12 | 52 |
| K950719 | Olympus America, Inc. | OES UROLOGY | 1996-12-11 | 664 |
| K945686 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ KNIVES, CURETTES | 1995-02-13 | 84 |
| K934730 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ ENDOSCOPIC COLD KNIFE BLADES | 1994-01-11 | 102 |
| K904939 | Olympus Corp. | FLEXIBLE AND RIGID URETEROTOME SYSTEM | 1992-01-07 | 432 |
Recalls for EZO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-22.
Frequently asked questions
What is FDA product code EZO?
EZO is the FDA product code for urethrotome. It is a Class II device, regulated under 21 CFR 876.4770 and reviewed by the Gastroenterology and Urology panel.
What device class is EZO?
Class II, regulation 21 CFR 876.4770. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EZO?
Across 5 cleared submissions the average was 267 days from receipt to decision (median 102).
Which companies have the most EZO clearances?
KARL STORZ Endoscopy-America, Inc. (2); Richard Wolf Medical Instruments Corp. (1); Olympus America, Inc. (1); Olympus Corp. (1).
Have EZO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code EZO
- Run a recall and safety report across every EZO manufacturer
- Watch product code EZO 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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