510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063259Substantially Equivalent

Olympus Capsule Endoscope System

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

K063259 is the FDA 510(k) clearance record for OLYMPUS CAPSULE ENDOSCOPE SYSTEM, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule). FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show no recalls naming K063259.

Clearance record

Decision date
Received
(319 days to decision)
Product code
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation
21 CFR 876.1300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corporation 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEZ

Trailing 12 months
2 clearances under product code NEZ in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NEZ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260