Panels › Gastroenterology, Urology › Product code PCV · Class 2
Endoscopic Leak Tester
Regulation 876.1500
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PCV
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Medical Systems Corp. | 1 | 0 |
| Pentax of America, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2021 | K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 Pentax of America, Inc. | PCV |
| Feb 4, 2013 | K123704 | AUTOMATED ENDOSCOPE LEAK TESTER Olympus Medical Systems Corp. | PCV |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.