LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251256

    Validate with FDA (Live)

    Device Name
    PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
    Manufacturer
    Pentax of America, Inc.
    Date Cleared
    2025-12-16

    (237 days)

    Product Code
    FDS
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K131902,K131855
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PENTAX Medical Video Upper GI Scopes (EG Family):
    This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.

    PENTAX Medical Video Colonoscopes (EC Family):
    This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

    Device Description

    PENTAX Medical Video Upper GI Scopes (EG Family)
    These instruments are intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.

    PENTAX Medical Video Colonoscopes (EC Family)
    These instruments are intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1