MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3— 510(k) K051613

Name: FDA 510(k) clearance K051613
Creator: U.S. Food and Drug Administration
Published: 2005-08-15

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K051613 for MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3, Substantially Equivalent on 2005-08-15. Applicant: Olympus Medical Systems Corporation. Device class: 2.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code ODA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2005-06-17
Decision date: 2005-08-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODA

view all

K232406 — KARL STORZ OR1 SCB CONTROL (WU300)2023-10-03
K221929 — Smith+Nephew INTELLIO Tablet2022-09-06
K203566 — Tablet Application2021-05-13
K192876 — INTELLIO Tablet Application2020-02-27
K153205 — IDSS ForceTriad Control Module2016-08-01

More clearances from Olympus Medical Systems Corporation

view all

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