510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123428Substantially Equivalent

Mirocam Capsule Endoscope System

IntroMedic Co., Ltd., Guro-Gu , Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123428 is the FDA 510(k) clearance record for MIROCAM CAPSULE ENDOSCOPE SYSTEM, a class II device, cleared for Intromedic Co., Ltd. on under FDA product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule). FDA records list 11 510(k) clearances for Intromedic Co., Ltd., from to . As of , FDA records show one recall naming K123428.

Clearance record

Decision date
Received
(194 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
Intromedic Co., Ltd. Suite 1104, E&C Venture Dream Tower 6-Cha, Guro-Gu , Seoul, KR
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