BEUDAMED
    Product Code: ODG FDA class 2 21 CFR 876.1500

    Endoscopic Ultrasound System, Gastroenterology-Urology

    Gastroenterology, Urology

    The Endoscopic Ultrasound System for Gastroenterology-Urology (product code ODG) is a diagnostic device combining endoscopy and ultrasound to provide ultrasonic visualization of body cavities accessible by endoscope, used in the GI and GU tracts for staging tumors, evaluating submucosal lesions, and guiding fine-needle aspiration. Reusable flexible endoscopes in this product code require validated reprocessing data in 510(k) submissions. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    43
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    19
    Years Active
    35

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    Basic Information

    Product Code
    ODG
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 43 510(k) clearances via K numbers.

    K Number Device Name
    K260428 RIVOS™ EUS Access Device (M00553900)
    K251859 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
    K251542 InstaFAN
    K231813 Ultrasonic Gastrovideoscope
    K232518 EndoSound Vision System; EVS
    K223616 Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
    K221238 FUJIFILM Ultrasonic Endoscope EG-740UT
    K221952 Endoscope Model EG-580UT and Endoscope Model EG-580UR
    K214089 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
    K212852 Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
    K203166 PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
    K200090 PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
    K183433 FUJIFILM Ultrasonic Endoscope
    K182004 PENTAX Medical Endoscopic Ultrasound System
    K180731 Ultramatrix EUS Balloon
    K171207 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
    K173184 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
    K172309 Endoscopic Ultrasound Aspiration Needle
    K162447 PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
    K163058 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
    K160845 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
    K133312 EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
    K130247 PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
    K130206 PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
    K112198 EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
    K110030 EXPECT ENDOSCOPIC ASPIRATION NEEDLE
    K090197 EG-3870UTK
    K090196 EG-3670URK
    K061068 EG-3670URK
    K042140 OLYMPUS BF TYPE UC160-OL8
    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K031347 ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
    K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    K011886 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
    K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE
    K010591 OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
    K982734 OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE
    K961048 OLYMPUS MH-246R BALLOON SHEATH
    K953876 PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
    K926514 ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20
    K904573 PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.