510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123704Substantially Equivalent

Automated Endoscope Leak Tester

Olympus Medical Systems Corp., Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123704 is the FDA 510(k) clearance record for AUTOMATED ENDOSCOPE LEAK TESTER, a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code PCV (Endoscopic Leak Tester). FDA's definition for product code PCV reads: "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". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show no recalls naming K123704.

Clearance record

Decision date
Received
(63 days to decision)
Product code
PCV Endoscopic Leak Tester
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corp. Regulatory Affairs & Quality Assurance, Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCV

Trailing 12 months

FDA records hold no clearances under product code PCV in the trailing twelve months.

FDA records show no clearances under product code PCV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260