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)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 452 | 12 |
| GCJ | Laparoscope, General & Plastic Surgery | 274 | 2 |
| MSD | Catheter, Hemodialysis, Implanted | 270 | 8 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 268 | 26 |
| NAY | System, Surgical, Computer Controlled Instrument | 248 | 16 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 217 | 11 |
| FDE | Laparoscopy Kit | 127 | 22 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 125 | 43 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 113 | 15 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 112 | 1 |
| KOD | Catheter, Urological | 108 | 1 |
| KNW | Instrument, Biopsy | 107 | 5 |
| EZL | Catheter, Retention Type, Balloon | 85 | 2 |
| KOB | Catheter, Suprapubic (And Accessories) | 66 | 0 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 61 | 0 |
Active product codes
| 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 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 0 | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 | 3 | 0 |
| FON | Bag, Drainage, With Adhesive, Ostomy | 1 | 0 | 3 |
| 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 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | 3 | 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 |
| EXG | Bag, Urine Collecting, Ureterostomy | 1 | 0 | 1 |
| 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 |
| FFT | Electrode, Ph, Stomach | 1 | 0 | 1 |
| FIE | Needle, Fistula | 2 | 1 | 0 |
| FIP | Subsystem, Water Purification | 2 | 1 | 0 |
| FKG | Tray, Start/Stop (Including Contents), Dialysis | 1 | 0 | 1 |
| 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 |
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Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Water bottle assembly. Model Number. OS-H5. Open, Classified |
PEA | K191282 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK. Open, Classified |
ODG | K182004 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK. Open, Classified |
ODG | K182004 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U. Open, Classified |
ODG | K200090 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR. Open, Classified |
ODG | K200090 |
| Oct 22, 2026 | Medtronic Neuromodulation InterStim Percutaneous Extensions
EXT 3560022 ISTM II PERC
3560022
EXT 3560030 ISTM MICRO PERC
3560030 Open, Classified |
EZW | None listed |
| Oct 22, 2026 | Medtronic Neuromodulation InterStim SureScan MRI Leads 978A1 & 978B1:
LEAD 978A128 ISTM MICRO 28CM SSMRI TINED
978A128
LEAD 978A133 ISTM MICRO 33CM SSMRI TINED
978A133
LEAD 978A141 ISTM MICRO 41CM SSMRI TINED
978A141
L Open, Classified |
QON | None listed |
| Oct 16, 2026 | Axonics, Inc. PNE Lead Implant Kit
REF: 1701 Open, Classified |
EZW | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
ADVANCE LAPAROSCOPIC
DYNJ911135
LAP CHOLE
DYNJ911660
LAP NISSEN
DYNJ911560
UROLOGY LAPAROSCOPIC - 51638
DYNJ908720A Open, Classified |
FDE | None listed |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC;
2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274A Open, Classified |
FDE | None listed |
| Oct 15, 2026 | Cook Incorporated Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112 Open, Classified |
FBK | K171602 |
| Oct 14, 2026 | W L Gore & Associates, Inc. Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis;
Model/Catalog Number: VSWVH0808 and VSWVN1006
Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-ex Open, Classified |
FGE | K170740 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 Open, Classified |
FEB | K082988 |
| Oct 14, 2026 | Steris Corporation RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 Open, Classified |
FEB | K082988 |
| Oct 9, 2026 | Boston Scientific Corporation NaviFlex LW Pusher;
Advx Panc. Stent 4/5F;
Material Number (UPN): M00535030; Open, Classified |
FGE | K223592 |
| Oct 2, 2026 | GRI Medical & Electronic Technology Co., Ltd. HALYARD Laparoscopy Comprehensive Pack II
REF: 49332 Open, Classified |
FDE | None listed |
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU;
2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV;
3) KI Open, Classified |
NWU | None listed |
| Sep 25, 2026 | American Contract Systems Inc Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays
ROBOTIC PACK - 242561
Model No. MHRB88AO Open, Classified |
FDE | None listed |
| Sep 25, 2026 | Bard Peripheral Vascular Inc EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software Open, Classified |
KNW | K252681 |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MAJOR PACK, Catalog Number: DYNJ81325A Open, Classified |
FDE | None listed |
| Sep 18, 2026 | Fresenius Medical Care Renal Therapies Group, LLC CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors;
Model Number: 03-2522-1; Open, Classified |
FJK | K213992 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. Open, Classified |
FGE | None listed |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA. Open, Classified |
KNS | K123319 |
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