Panels › Gastroenterology, Urology
Gastroenterology, Urology devices
435 product codes reviewed by the Gastroenterology, Urology panel. 11,354 510(k) clearances and 4,428 recalls in the FDA data, 79% of those recalls name a 510(k).
240510(k)s in 12 months
323recalls in 12 months
3,512recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 4 | 43 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 29 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 3 | 26 |
| NAY | System, Surgical, Computer Controlled Instrument | 2 | 10 | 16 |
| FDE | Laparoscopy Kit | 2 | 0 | 22 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 10 | 12 |
| FEB | Accessories, Cleaning, For Endoscope | 2 | 1 | 20 |
| FJL | Resectoscope | 2 | 1 | 18 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 | 7 | 11 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 2 | 2 | 15 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 | 13 | 1 |
| KNW | Instrument, Biopsy | 2 | 9 | 5 |
| EZD | Catheter, Straight | 2 | 12 | 0 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 2 | 2 | 8 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 2 | 9 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 | 2 | 7 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | 8 | 0 |
| MSD | Catheter, Hemodialysis, Implanted | 2 | 0 | 8 |
| OWN | Confocal Optical Imaging | 2 | 8 | 0 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | 7 | 0 |
| OHR | Catheter Care Tray | 2 | 0 | 7 |
| EZL | Catheter, Retention Type, Balloon | 2 | 4 | 2 |
| FAD | Stent, Ureteral | 2 | 2 | 4 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 | 6 | 0 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 | 6 | 0 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 2 | 0 | 6 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 2 | 2 | 4 |
| QNP | Gastrointesinal Lesion Software Detection System | 2 | 6 | 0 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 5 | 0 |
| OCW | Endoscopic Tissue Approximation Device | 2 | 2 | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 | 3 | 1 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 2 | 3 | 1 |
| FEO | Lithotriptor, Ultrasonic | 2 | 0 | 4 |
| FFX | System, Gastrointestinal Motility (Electrical) | 2 | 2 | 2 |
| KDN | System, Perfusion, Kidney | 2 | 3 | 1 |
| KNQ | Dilator, Esophageal | 2 | 0 | 4 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 | 0 | 4 |
| KQT | Evacuator, Gastro-Urology | 2 | 0 | 4 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 2 | 0 | 4 |
| ODC | Endoscope Channel Accessory | 2 | 1 | 3 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 | 3 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 | 3 | 0 |
| LQR | Dislodger, Stone, Biliary | 2 | 1 | 2 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 2 | 0 | 3 |
| NWU | Endoscope Introducer Kit | 2 | 0 | 3 |
| PPB | Foley Catheter Kit (Excludes Hiv Testing) | 2 | 0 | 3 |
| EYB | Catheter, Ureteral, Gastro-Urology | 2 | 0 | 2 |
| GBM | Catheter, Urethral | 2 | 0 | 2 |
| GCP | Endoscope, Ac-Powered And Accessories | 2 | 0 | 2 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 2 | 0 | 2 |
| KOD | Catheter, Urological | 2 | 1 | 1 |
| KPL | Colonic Irrigation System | 2 | 0 | 2 |
| LJH | System, Irrigation, Urological | 2 | 2 | 0 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 2 | 2 | 0 |
| MYE | System, Electrogastrography (Egg) | 2 | 2 | 0 |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 2 | 2 | 0 |
| OCX | Endoscopic Irrigation/Suction System | 2 | 0 | 2 |
| PIO | Enteral Specific Transition Connectors | 2 | 0 | 2 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 2 | 2 | 0 |
| PPD | Universal Drainage Tray | 2 | 0 | 2 |
| PPO | Multi-Lumen Hemodialysis Catheterization Kit | 2 | 0 | 2 |
| QKA | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | 2 | 2 | 0 |
| QXM | Implanted Tibial Electrical Urinary Continence Device | 2 | 2 | 0 |
| QZF | Gastrointestinal Capsule Endoscopy Analysis Software Device | 2 | 2 | 0 |
| EXQ | Cystometer, Electrical Recording | 2 | 1 | 0 |
| EXY | Uroflowmeter | 2 | 0 | 1 |
| EZC | Catheter, Coude | 2 | 0 | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 2 | 1 | 0 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 1 | 0 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 2 | 1 | 0 |
| FDA | Enteroscope And Accessories | 2 | 1 | 0 |
| FDI | Snare, Flexible | 2 | 1 | 0 |
| FDX | Endoscopic Cytology Brush | 2 | 1 | 0 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | 2 | 0 | 1 |
| FIE | Needle, Fistula | 2 | 1 | 0 |
| FIP | Subsystem, Water Purification | 2 | 1 | 0 |
| FKH | Solution-Test Standard-Conductivity, Dialysis | 2 | 0 | 1 |
| FKJ | Filter, Blood, Dialysis | 2 | 1 | 0 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 2 | 1 | 0 |
| KGE | Forceps, Biopsy, Electric | 2 | 1 | 0 |
| KNY | Accessories, Catheter, G-U | 2 | 1 | 0 |
| LFJ | Catheter, Subclavian | 2 | 0 | 1 |
| LYK | Angioscope | 2 | 1 | 0 |
| MJC | Catheter, Urological (Antimicrobial) And Accessories | 2 | 0 | 1 |
| MND | Ligator, Esophageal | 2 | 0 | 1 |
| MPA | Endoilluminator | 2 | 1 | 0 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | 2 | 1 | 0 |
| NHV | System, Water Purification, General Medical Use | 2 | 1 | 0 |
| NYV | Gastrointestinal Motility System, Capsule | 2 | 1 | 0 |
| OCU | Endoscopic Storage Cover | 2 | 0 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 2 | 1 | 0 |
| PCU | Pancreatic Stent, Covered, Metallic, Removable | 2 | 1 | 0 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | 2 | 0 | 1 |
| PEV | Dialysis Administration Kit | 2 | 0 | 1 |
| PLL | Submucosal Injection Agent | 2 | 1 | 0 |
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | 1 | 0 |
| POZ | Biopsy Needle Kit | 2 | 0 | 1 |
| QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence | 2 | 1 | 0 |
| QAX | Hemodialyzer With Expanded Solute Removal Profile | 2 | 1 | 0 |
| QFQ | Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | 2 | 1 | 0 |
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