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

    APPOSE SKIN STAPLER

    K Number: K811030 · Decision May 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    41
    Applicant Total
    45
    Review Days
    41

    Basic Information

    Device Name
    APPOSE SKIN STAPLER
    K Number
    K811030
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    DAVIS & GECK, INC.
    Date Received
    April 16, 1981
    Decision Date
    May 27, 1981
    Product Code
    GAG
    Advisory Committee
    General Hospital
    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
    GAG Stapler, Surgical

    Similar 510(k) Clearances

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

    AEON™ Endoscopic Powered Stapler

    FDA 510(k)
    FDA Class 2 ·General Hospital

    da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GIA™ Stapler with Tri-Staple™ Technology

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by DAVIS & GECK, INC.

    K Number Device Name
    K982853 SILK SUTURE
    K981582 SURGILON, DERMALON, & OPHTHALON
    K974015 ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
    K980610 DEXON RAPID (DEXON R)
    K980062 MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
    K973409 KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
    K970857 ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
    K972139 ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
    K972566 DEXON VIOLET
    K962971 POLYPROPYLENE MESH (VARIOUS SIZES)
    Search all 45 clearances from DAVIS & GECK, INC. →