BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HK SURGICAL, INC.

    Reg #: 2027804 · FEI: 1000125732 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    39
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    HK SURGICAL, INC.
    Registration Number
    2027804
    FEI Number
    1000125732
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1271 PUERTA DEL SOL
    City
    SAN CLEMENTE
    State
    CA
    ZIP
    92673
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123822

    Owner / Operator

    Firm Name
    HK SURGICAL, INC.
    Operator Number
    9000274
    Address
    1271 PUERTA DEL SOL, --
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US

    Products

    Device Name Product Code
    Pump, Infusion FRN
    System, Suction, Lipoplasty For Removal QPB
    Tray, Biopsy, Without Biopsy Instruments FCH
    Cannula, Surgical, General & Plastic Surgery GEA
    Stand, Infusion FOX
    Fiber, Medical, Absorbent FRL
    Syringe, Irrigating (Non Dental) KYZ
    Splint, Extremity, Noninflatable, External, Sterile FYH
    Gown, Examination FME
    Tubing, Noninvasive GAZ
    Accessories, Catheter KGZ
    Binder, Elastic KMO

    Proprietary Names

    Klein Touch Pump HK CV Single Spike Infiltration Tubing Double Spike Infiltration Tubing HK 2X Infiltration Tubing Single Spike Infiltration Tubing Klein Tumescent Infiltration Pump KTIP HK Klein TDD Pump HK ASPIRATOR HK Biopsy Vial Holder Klein Infiltration Pump KIP-II KIP-II+ Monty Cannulas Infiltration Cannulas Capistrano Cannulas Aspiration Cannulas Single Use Infiltration Cannulas Single Use Monty Cannulas IV POLE KIP IV POLE BRACKET KLEIN CART HK SUPER ABSORBANT PADS HK Klein Tumescent Delivery (TD) Syringe Tubing-HK-2TDST HK Klein Tumescent Delivery (TD) Syringe Tubing-HK-1TDST THIGH-A-SIDE MIDINE EXAM PANTIES Aspiration Tubing Fine Touch Tubing HEAVY ASPIRATION TUBING ITD-20 ITS-10RS ITS-10 IT2X-10 CVT-10-VS ITS-20 CVT-20 CVT-10 HK Binder

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device