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

    CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)

    K Number: K211579 · Decision Sep 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    5
    Review Days
    109

    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
    CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
    K Number
    K211579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bolder Surgical, LLC
    Date Received
    May 21, 2021
    Decision Date
    September 7, 2021
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    Similar 510(k) Clearances

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

    Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

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

    CoolSeal Generator® (CSL-200-90)

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

    NEUROMARK System (NMK00301)

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

    LAP-iX2N

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

    OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

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

    MILAN System

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

    Other Clearances by Bolder Surgical, LLC

    K Number Device Name
    K231012 CoolSeal Trinity
    K203183 CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
    K203640 CoolSeal Reveal
    K202114 CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20