BEUDAMED
    Product Code: GCA FDA class 2 21 CFR 876.5010

    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

    Gastroenterology, Urology

    The Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA) is a catheter designed to remove stones from the biliary tract and may additionally allow flushing with irrigating fluid and injection of contrast agents for imaging during the procedure. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence. The device is regulated under 21 CFR 876.5010 in the Gastroenterology, Urology specialty (GU). It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    26
    FEI Numbers
    34
    Registration Numbers
    34
    Unique Applicants
    18
    Years Active
    48

    Basic Information

    Product Code
    GCA
    Device Class
    FDA class 2
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 26 510(k) clearances via K numbers.

    K Number Device Name
    K253013 Disposable Stone Retrieval Balloon Catheter
    K232752 Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
    K212582 SpyGlass Discover Balloon Dilation Catheter
    K210660 Stone Retrieval Balloon Catheter
    K200173 Stone Retrieval Balloon
    K200247 Fusion Quattro Extraction Balloon
    K193344 Tri-Ex Extraction Balloon with Multiple Sizing
    K173659 Howell D.A.S.H Extraction Balloon with Multiple Sizing
    K173414 Advance Biliary Balloon Catheter
    K170292 Tri-Ex Extraction Balloon With Multiple Sizing
    K063677 FUSION QUATTRO EXTRACTION BALLOON XL
    K040129 TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
    K011018 TAUT BALLOON CATHETER, MODEL 50640
    K980917 ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
    K953951 WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
    K931619 MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
    K920342 BARD STONE REMOVAL BALLOON CATHETER
    K915129 CATHETER WITH INTRODUCER AND SYRINGES
    K915343 URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
    K914755 DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
    K915506 LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
    K913294 SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
    K911487 LAPAROSCOPIC CHOLANGIOCATH
    K910917 CATHLAB SILICONE BILIARY BALLOON CATHETER
    K911181 INTIMAX(TM) IRRIGATION CATHETER
    K772292 T-TUBE WHELAN-MOSS

    FEI Numbers

    This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.