AUTOMATED ENDOSCOPE LEAK TESTER— 510(k) K123704

Name: FDA 510(k) clearance K123704
Creator: U.S. Food and Drug Administration
Published: 2013-02-04

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K123704 for AUTOMATED ENDOSCOPE LEAK TESTER, Substantially Equivalent on 2013-02-04. Applicant: Olympus Medical Systems Corp.. Device class: 2.

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code PCV
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2012-12-03
Decision date: 2013-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PCV

view all

K212201 — PENTAX Medical Auto Leakage Tester SHA-P62021-10-01

More clearances from Olympus Medical Systems Corp.

view all

K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB2026-09-10
K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) +2 more2026-07-01
K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more2026-05-21
K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)2026-04-23
K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR2026-03-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.