510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K100345Substantially Equivalent

Systems Integration Model: Endoalpha

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

K100345 is the FDA 510(k) clearance record for SYSTEMS INTEGRATION MODEL: ENDOALPHA, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code ODA (Endoscopic Central Control Unit). FDA's definition for product code ODA reads: "To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command". FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show no recalls naming K100345.

Clearance record

Decision date
Received
(45 days to decision)
Product code
ODA Endoscopic Central Control Unit
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corporation Regulatory Affairs & Quality, Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODA

Trailing 12 months

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

FDA records show no clearances under product code ODA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODA, 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