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    Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets

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

    Percutaneous Nephrostomy Drainage Catheter & Set

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·MANISH MEDI INNOVATION PRIVATE LIMITED·26 devices

    RE-ENTRY? MALECOT NEPHROSTOMY CATHETER SET

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code GBO·November 18, 2014

    JINRO PIGTAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code GBO·February 13, 2025

    NEPHROSTOMY CATHETER SETS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code GBO·January 28, 2025

    EXODUS DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code FGE·October 25, 2021

    NEPHROSTOMY CATHETER SETS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code GBO·February 10, 2025

    JINRO PIGTAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code GBO·February 18, 2025

    ULTRATHANE NEPHROSTOMY SET

    FDA Adverse Event
    Injury ·COOK INC·Product code GBO·October 12, 2017

    MALECOT NEPHROSTOMY CATHETERS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code GBO·May 22, 2025

    Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·March 28, 2018

    Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·March 28, 2018

    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·March 28, 2018

    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·March 28, 2018

    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·March 28, 2018

    COOK COPE-LOOP NEPHROSTOMY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJE·March 11, 2022

    Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GBO·December 12, 2017

    Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GBO·December 12, 2017

    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GBO·December 12, 2017

    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GBO·December 12, 2017