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Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated vs MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation: FDAPulse comparison

MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation's review days of 263 is 1.0x Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated's 262 (85th percentile). Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated is dated 2026-09-11; MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation 2026-09-18.

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

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How does Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated compare to MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation?

FieldPotenza Prime (K254185): 510(k) cleared for Jeisys Medical IncorporatedMINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation
Record510(k) clearance510(k) clearance
510(k) numberK254185K254238
DevicePotenza PrimeMINT MONO Sutures
ApplicantJeisys Medical IncorporatedHans Biomed Corporation
Specialty / panelGeneral, Plastic SurgeryGeneral, Plastic Surgery
Product codeGEINEW
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2025-12-232025-12-29
Decision date2026-09-112026-09-18
Review time (days)262263
Third-party reviewNoNo
Applicant locationSeoul, KRYuseong-Gu, KR
amount percentile84th85th
Predicate Speed & CAPA Advisory Opportunity Score55/10055/100
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Official records: Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated · MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation

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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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