BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    P-S SURGICAL DRAIN

    K Number: K801442 · Decision Jul 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    40
    Review Days
    24

    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
    P-S SURGICAL DRAIN
    K Number
    K801442
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Pudenz-Schulte Medical Research Corp.
    Date Received
    June 20, 1980
    Decision Date
    July 14, 1980
    Product Code
    GCY
    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
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

    Similar 510(k) Clearances

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

    REDYROB-CLOSED WOUND DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ODONTIT AUTOGENOUS BONE COLLECTION DEVICE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PENROSE DRAIN MODELS 6001 - 6007

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MACRO SUCTION TUBE MODEL NO 10061

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PRESSURE IRRIGATING SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Pudenz-Schulte Medical Research Corp.

    K Number Device Name
    K960055 MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
    K954409 PS MEDICAL IPI VASCULAR ACCESS CATHETER
    K951258 PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
    K934796 IPI LOW PROFILE IMPORT
    K934167 IPI DUAL LUMEN PORT
    K940096 PS MEDICAL CATHETER PLACEMENT KIT
    K934545 PS MEDICAL DELTA BURR HOLE VALVE
    K930206 PS MEDICAL IPI ACCESS KIT
    K930606 PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
    K913412 PS MEDICAL CSF-ACCESS DEVICE
    Search all 40 clearances from Pudenz-Schulte Medical Research Corp. →