FDA 510(k)

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)

K-Nummer: K234114 · 2024-08-20

AntragstellerOkapi Medical, LLC Dba Resivant Medical

Entscheidungsdatum2024-08-20

ProduktcodeMPN

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) is the device name listed in this FDA 510(k) record. The listed applicant is Okapi Medical, LLC Dba Resivant Medical. It received FDA 510(k) clearance on 2024-08-20 under 510(k) number K234114. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)?

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is Okapi Medical, LLC Dba Resivant Medical. The 510(k) number is K234114.

When did CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) receive FDA 510(k) clearance?

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) received FDA 510(k) clearance on 2024-08-20, under 510(k) number K234114.

Who is the listed applicant for CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)?

The FDA 510(k) record lists Okapi Medical, LLC Dba Resivant Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)?

The FDA product code for CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) is MPN.

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Weitere Einträge mit Okapi Medical, LLC Dba Resivant Medical als Antragsteller

K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)

Verwandte Geräte (Code: MPN)

K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical K233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical , Ltd.K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited.K212246Exofin Precision PenChemence Medical, Inc.K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc.

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