BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORIGAMI SURGICAL Inc.

    Reg #: 3010860245 · FEI: 3010860245 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    ORIGAMI SURGICAL Inc.
    Registration Number
    3010860245
    FEI Number
    3010860245
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    79 Haven St.
    City
    Dover
    State
    MA
    ZIP
    02030
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123811

    Owner / Operator

    Firm Name
    Origami Surgical Inc.
    Operator Number
    10046386
    Address
    79 Haven St.
    City
    Dover
    State
    MA
    Postal Code
    02030
    Country
    US
    Correspondent
    John Gillespie

    Products

    Device Name Product Code
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    Laparoscope, General & Plastic Surgery GCJ
    System, Surgical, Computer Controlled Instrument NAY
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Tray, Surgical, Needle FSH

    Proprietary Names

    StitchKit StitchKit HE, StitchKit BA, StitchKit PR, StitchKit RSCP, StitchKit RHP StitchKit PARK

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility