510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K183053Substantially Equivalent

Olympus Small Intestinal Capsule Endoscope System

Olympus Medical Systems Corp., Hachioji-Shi, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183053 is the FDA 510(k) clearance record for Olympus Small Intestinal Capsule Endoscope System, a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule). FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show no recalls naming K183053.

Clearance record

Decision date
Received
(123 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 Corp. 2951 Ishikawa-Cho, Hachioji-Shi, JP
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 October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NEZ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260