510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IntroMedic Co., Ltd.

Seoul, KR

INTROMEDIC CO., LTD appears in FDA device records in Seoul, KR. FDA records list 11 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 11 510(k) clearances for IntroMedic Co., Ltd. between 2011 and 2026. The busiest year on record is 2012, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for IntroMedic Co., Ltd., by decision year
YearClearances
20111
20122
20132
20142
20151
20182
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252617MiroCam® Capsule Endoscope SystemNEZSubstantially Equivalent
K180732MiroCam Capsule Endoscope SystemNEZSubstantially Equivalent
K170438MiroCam Capsule Endoscope SystemNEZSubstantially Equivalent
K143663MiroCam Capsule Endoscope SystemNEZSubstantially Equivalent
K134005MIROCAM CAPSULE ENDOSCOPE SYSTEMNEZSubstantially Equivalent
K140751MIROCAM CAPSULE ENDOSCOPE SYSTEMNEZSubstantially Equivalent
K131131E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEMEOXSubstantially Equivalent
K123428MIROCAM CAPSULE ENDOSCOPE SYSTEMNEZSubstantially Equivalent
K120702E.G. SCAN II ESPHAGOSCOPE SYSTEMEOXSubstantially Equivalent
K111450MIROCAM CAPSULE ENDOSCOPE SYSTEMNEZSubstantially Equivalent
K111030E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEMEOXSubstantially Equivalent

Registered establishments

FDA registered establishments for IntroMedic Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30072441273007244127INTROMEDIC CO., LTDSuite 1105 1106 E&C Venture Dream Tower 6-Cha, Seoul 152-719 KR2026
30136843283013684328IntroMedic Co., Ltd.F-RTEK 4F, 11-25, Simin-daero 327 beon-gil, Anyang-si Gyeonggi 14055 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1615-2018Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain