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

    ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP

    K Number: K962258 · Decision Sep 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    111
    Review Days
    91

    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
    ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
    K Number
    K962258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon Endo-Surgery, Inc.
    Date Received
    June 12, 1996
    Decision Date
    September 11, 1996
    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 Ethicon Endo-Surgery, Inc.

    K Number Device Name
    K141952 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
    K111195 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
    K110385 ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
    K101520 ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
    K102632 ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
    K093896 ETHICON ENDO SURGERY SLOTTED ANOSCOPE
    K091259 ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
    K091824 ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
    K093236 ETHICON ENDO-SURGERYOPTICAL DILATOR
    K091290 ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
    Search all 111 clearances from Ethicon Endo-Surgery, Inc. →