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ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH vs MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies: FDAPulse comparison

ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH's review days of 168 is 1.5x MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies's 115 (61st percentile). ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH is dated 2026-09-11; MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies 2026-10-15.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH compare to MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies?

FieldANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbHMICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies
Record510(k) clearance510(k) clearance
510(k) numberK261019K262097
DeviceANTERIONMICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)
ApplicantHeidelberg Engineering GmbHCarl Zeiss Meditec Cataract Technologies
Specialty / panelOphthalmicOphthalmic
Product codeOBOHQC
Device class22
Clearance typeTraditionalSpecial
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-03-272026-06-22
Decision date2026-09-112026-10-15
Review time (days)168115
Third-party reviewNoNo
Applicant locationHeidelberg, DEReno, NV, US
amount percentile61st42nd
Predicate Speed & CAPA Advisory Opportunity Score42/10041/100
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Official records: ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH · MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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