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

    MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE

    K Number: K081002 · Decision Jun 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    4
    Review Days
    62

    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
    MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
    K Number
    K081002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sutures India Pvt., Ltd.
    Date Received
    April 8, 2008
    Decision Date
    June 9, 2008
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

    Similar 510(k) Clearances

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

    Trexon™ Monofilament Synthetic Absorbable Suture

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

    MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture

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

    STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

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

    TroClose 1200

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

    PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)

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

    Monotime and Optime R

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

    Other Clearances by Sutures India Pvt., Ltd.

    K Number Device Name
    K081001 PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
    K081003 TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
    K060018 TRULENE MESH