FDA product code PCV: Endoscopic Leak Tester
PCV is the FDA product code for endoscopic leak tester. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under PCV, from 2 different applicants. The average 510(k) review took 71 days (median 71).
Definition
An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Leak Tester |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PCV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 79 |
Compare with all 510(k) review times · Search every PCV clearance
Top PCV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pentax of America, Inc. | 1 | 2021-10-01 |
| Olympus Medical Systems Corp. | 1 | 2013-02-04 |
Most recent PCV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212201 | Pentax of America, Inc. | PENTAX Medical Auto Leakage Tester SHA-P6 | 2021-10-01 | 79 |
| K123704 | Olympus Medical Systems Corp. | AUTOMATED ENDOSCOPE LEAK TESTER | 2013-02-04 | 63 |
Recalls for PCV devices
openFDA lists no recalls for product code PCV.
Frequently asked questions
What is FDA product code PCV?
PCV is the FDA product code for endoscopic leak tester. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is PCV?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCV?
Across 2 cleared submissions the average was 71 days from receipt to decision (median 71).
Which companies have the most PCV clearances?
Pentax of America, Inc. (1); Olympus Medical Systems Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCV
- Run a recall and safety report across every PCV manufacturer
- Watch product code PCV 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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