BEUDAMED
    Product Code: KDD FDA class 1 21 CFR 878.4800

    Kit, Surgical Instrument, Disposable

    General, Plastic Surgery

    A disposable surgical instrument kit is a pre-assembled, single-use collection of surgical tools packaged together for a specific procedure or general surgical use, intended to reduce processing time and eliminate the risk of cross-contamination associated with reusable instruments. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KDD is regulated under 21 CFR 878.4800 in the General, Plastic Surgery medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    51
    FEI Numbers
    323
    Registration Numbers
    324
    Unique Applicants
    44
    Years Active
    32

    Basic Information

    Product Code
    KDD
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 51 510(k) clearances via K numbers.

    K Number Device Name
    K072814 CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
    K011514 INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
    K971317 NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
    K960456 DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
    K932219 SUTURE SET OR LACERATION TRAYS (PACKS)
    K923176 SURGICAL INSTRUMENT KIT, DISPOSABLE
    K925905 KIT, SURGICAL INSTRUMENT, DISPOSABLE
    K924958 BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY
    K925215 STERILE SURGICAL INSTRUMENT TRAYS
    K924117 DEXIDE LAPAROSCOPIC KITS
    K920989 SURGICAL INSTRUMENT KIT, DISPOSABLE
    K920763 LACERATTION TRAY
    K920516 GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
    K914244 STERILE CUSTOM SURGICAL KITS
    K913049 SLIP-PRUF-CLINGER
    K911606 BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
    K910816 IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE
    K910369 INCISION AND DRAINAGE KIT
    K910366 MEGA GENERAL PURPOSE INSTRUMENT KIT
    K902441 DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)
    K880785 SKILCRAFT
    K874063 ENTERON ABDOMINAL PARACENTESIS TRAY
    K870373 STERILE PROCEDURAL TRAYS
    K864969 JMS HALO APPLICATION TRAY
    K853910 SUTURE REMOVAL KIT
    K850325 STERILE SUTURE REMOVAL KIT
    K842627 C-SECTION TRAY
    K843115 STERILE SOLUTION BOWL
    K834135 STERILE SUTURE BOOTS
    K833438 PREPACELL-STERILE-BONE MARROW ASPIR
    K832628 VYGON THORACIC DRAINAGE-VARIOUS #'S
    K831841 STERILE DISP. INSTRUMENT TRAYS
    K832047 STERILE SUTURE REMOVAL SET
    K831795 FIRST AID KITS
    K822158 OPEN HEART TRAY (CUSTOM DESIGNED)
    K821814 HEMO-NATE L-P KIT
    K821502 STERILE SUTURE REMOVAL KIT
    K821500 STERILE CATH CARE KIT
    K821501 STERILE TRACHEOSTOMY CARE KIT
    K820423 SUTURE REMOVAL TRAY
    K813103 ACKRAD INCISION & DRAIN SET
    K811855 SKIN SCRUB KITS
    K811086 SUTURE REMOVAL SET(DISPLSABLE)
    K803199 SUTURE REMOVAL KIT
    K802557 EMERGENCY DEPARTMENT LACERATION KIT-
    K802019 SUTURE REMOVAL SET CAT.#906
    K780488 INSTRUMENT AND ACCESSORY KIT
    K771448 STERILE SUTURE REMOVAL KIT
    K770149 MAJOR SUTURE REMOVAL TRAY
    K761193 SUTURE REMOVAL KIT
    K760051 TRAY, SUTURE REMOVAL

    FEI Numbers

    This FDA classification entry is associated with 323 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 324 registration numbers. Click on an entry to view related FDA registrations.