Class Class II

CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (K250950)

K250950 2025-08-04 Traditional
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Description

CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) by Okapi Medical, LLC Dba Resivant Medical, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250950
Clearance Date2025-08-04
Clearance TypeTraditional
Product CodeMPN
Regulation Number878.4010

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Predicate lineage for K250950

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) (K250950) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K234114CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS...Okapi Medical, LLC Dba Resivant Med...2024

Trace the full predicate network for K250950

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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