510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981993Substantially Equivalent

Olympus Integrated Endosurgery System Endoalpha

Olympus Optical Co., Ltd., Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981993 is the FDA 510(k) clearance record for OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA, a class II device, cleared for The Olympus Optical Co. 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 48 510(k) clearances for The Olympus Optical Co., from to . As of , FDA records show no recalls naming K981993.

Clearance record

Decision date
Received
(74 days to decision)
Product code
ODA Endoscopic Central Control Unit
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
The Olympus Optical Co. Endoscope Division, Melville NY
510(k) summary
Summary
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