FCY
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bulb, Inflation, For Endoscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.
- Adverse events (MAUDE)
- 1997: 2 · 2021: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 (K093718) | Zutron Medical, LLC | 2010-02-22 |
| ANEROID BLOOD PRESSURE GAUGE (K904376) | Biomedical Dynamics, Inc. | 1990-12-20 |
| TRANS/R - FP(3) (K900016) | CIVCO Medical Instruments Co., Inc. | 1990-06-11 |
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Every clearance here is in the API, with alerts when new ones post.