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

    SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H

    K Number: K091759 · Decision Sep 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    81
    Review Days
    94

    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
    SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
    K Number
    K091759
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Medical Systems Corporation
    Date Received
    June 16, 2009
    Decision Date
    September 18, 2009
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

    Similar 510(k) Clearances

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

    XNY Disposable Gastric Calibration Tube

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Flexi-Seal AIR (with ENFit Connector)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    hygh-tec Drainage II

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Entarik NI Feeding Tube System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CORGRIP* SR NG/NI Tube Retention System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Olympus Medical Systems Corporation

    K Number Device Name
    K252050 Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
    K250993 Single Use Cytology Brush V (BC-V600P-3010)
    K252889 Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
    K250409 Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
    K252247 Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
    K250351 Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
    K252150 Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
    K250187 Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)
    K251859 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
    K251986 AUXILIARY WATER TUBE MAJ-855
    Search all 81 clearances from Olympus Medical Systems Corporation →