BEUDAMED
    Product Code: KGC FDA class 2 21 CFR 876.5980

    Tube, Gastro-Enterostomy

    Gastroenterology, Urology

    Gastro-Enterostomy Tube is a medical device inserted through the abdominal wall into the stomach and small intestine to provide enteral nutrition, fluid administration, or gastrointestinal decompression in patients who cannot be fed orally or who require gastrointestinal access for therapeutic purposes. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KGC, regulated under 21 CFR 876.5980, within the Gastroenterology, Urology medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    26
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    18
    Years Active
    47

    Basic Information

    Product Code
    KGC
    Device Class
    FDA class 2
    Regulation Number
    876.5980
    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
    K242211 PUMA-G Pediatric System
    K223916 PUMA-G System
    K193612 AMT Suture Delivery System
    K191844 Fidmi Low Profile Enteral Feeding Device
    K182832 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
    K183057 PUMA-G System
    K170323 Entuit Start Initial Placement Gastrostomy Set
    K120587 AMT T-FASTENER ANCHOR KIT
    K093312 KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
    K073718 MEDLINE GASTROSTOMY TUBE
    K080253 KIMBERLY-CLARK INTRODUCER KITS
    K980145 AMT DECOMPRESSION TUBES
    K910492 BARD REPLACEMENT GASTROSTOMY TUBE
    K910584 ONE STEP BUTTON(TM)
    K904779 BUTTON REPLACEMENT GASTROSTOMY DEVICE
    K904801 ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE
    K903086 TUBE GASTROSTOMY
    K903036 P.R.G. GUIDEWIRE PLACEMENT SYSTEM
    K901795 GASTROSTOMY FEEDING CATHETER
    K901791 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH.
    K902121 LAKE GASTROSTOMY TUBE
    K900884 P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY
    K901501 CORPAK GASTROSTOMY TUBE
    K894653 NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR
    K860441 ENTROKIT WITH MAGLINTE CATHETER
    K781333 CENTRAL CATHETER TRAY

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.