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

    INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE

    K Number: K945288 · Decision Dec 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    14
    Review Days
    32

    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
    INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE
    K Number
    K945288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helix Medical, Inc.
    Date Received
    October 31, 1994
    Decision Date
    December 2, 1994
    Product Code
    EWL
    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
    EWL Prosthesis, Laryngeal (Taub)

    Similar 510(k) Clearances

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

    FirstFit Surgical Kit

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

    PROVOX FREEHANDS FLEXIVOICE

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

    PROVOX VEGA PUNCTURE SET

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

    PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

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

    BLOM-SINGER INDWELLING TEP OCCLUDER

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

    PROVOX VEGA, MODEL 8130-8135

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

    Other Clearances by Helix Medical, Inc.

    K Number Device Name
    K023259 INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
    K991587 BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
    K945287 INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
    K932120 BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
    K932163 BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
    K930105 BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.
    K920090 BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET
    K915786 BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.
    K904729 BLOM-SINGER SHOWER GUARD
    K902112 BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT
    Search all 14 clearances from Helix Medical, Inc. →