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
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| 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 |
| QNA | Ultrasonic Urinary Stone Propulsion Device | 2 | 1 | 0 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | 3 | 0 | 1 |
| QRC | Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation | 2 | 1 | 0 |
| QSM | System, Surgical, Computer Controlled Instrument, Remanufactured | 2 | 1 | 0 |
| QZB | Software Controlled Endoscope And Instrument Holder | 2 | 1 | 0 |
| SFE | Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation | 2 | 1 | 0 |
| SGY | Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant | 2 | 1 | 0 |
| SHU | Appendiceal Scope And Accessories, Flexible | 2 | 1 | 0 |
| SHV | Reusable Intermittent Urinary Catheter System | 2 | 1 | 0 |
| SJB | Powered Fecal Management System | 2 | 1 | 0 |
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