BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MEROGEL CONTROL GEL ENT SURGICAL DRESSING

    K Number: K002972 · Decision Dec 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    32
    Applicant Total
    9
    Review Days
    84

    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
    MEROGEL CONTROL GEL ENT SURGICAL DRESSING
    K Number
    K002972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Xomed
    Date Received
    September 22, 2000
    Decision Date
    December 15, 2000
    Product Code
    KHJ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

    Similar 510(k) Clearances

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

    Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Biodesign Otologic Repair Graft

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Biodesign Otologic Repair Graft

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BIODESIGN ENT REPAIR GRAFT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Medtronic Xomed

    K Number Device Name
    K202623 Novapak Nasal Sinus Packing and Stent
    K122434 MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
    K031510 NIM-SPINE
    K002224 XPS 3000 SYSTEM
    K000728 MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
    K990793 ACCUGUIDE MUSCLE INJECTION MONITOR
    K963727 HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
    K963246 TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT