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UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG vs MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.: FDAPulse comparison

UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG's review days of 168 is 1.2x MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.'s 140 (61st percentile). UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG is dated 2026-09-18; MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. 2026-10-16.

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

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How does UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG compare to MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.?

FieldUNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KGMODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK261102K261782
DeviceUNIDRIVE Select SystemMODO DUO Electric Pump (B11621, B11673)
ApplicantKarl Storz SE & CO. KGTomy International, Inc.
Specialty / panelObstetrics/GynecologyObstetrics/Gynecology
Product codeHIHHGX
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-04-032026-05-29
Decision date2026-09-182026-10-16
Review time (days)168140
Third-party reviewNoNo
Applicant locationTuttlingen, DEDyersville, IA, US
amount percentile61st52nd
Predicate Speed & CAPA Advisory Opportunity Score42/10036/100
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Official records: UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG · MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.

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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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