BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Meriglu Topical Skin Adhesive

    K Number: K230981 · Decision Mar 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    12
    Review Days
    346

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Meriglu Topical Skin Adhesive
    K Number
    K230981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    M/s. Meril Endo Surgery Private Limited.
    Date Received
    April 5, 2023
    Decision Date
    March 16, 2024
    Product Code
    MPN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPN Tissue Adhesive For The Topical Approximation Of Skin

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MPN), ordered by most recent decision date.

    BondEase 2 Topical Skin Adhesive

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

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

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

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

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CM005 Standard (CM005); CM004 Mini (CM004)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Exofin Precision Pen

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Exofin High Viscosity Topical Skin Adhesive

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by M/s. Meril Endo Surgery Private Limited.

    K Number Device Name
    K252644 PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
    K233386 Monik™ - Disposable Endoscopic Trocar
    K232246 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
    K200452 Meril-Bonewax
    K200320 Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
    K200166 Mirus Ligating Clip, Mirus Ligating Clip Applier
    K172146 MERISTEEL
    K172149 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
    K172659 MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
    K160623 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
    Search all 12 clearances from M/s. Meril Endo Surgery Private Limited. →