FDA product code FCY: Bulb, Inflation, For Endoscope
FCY is the FDA product code for bulb, inflation, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FCY, from 3 different applicants. The average 510(k) review took 109 days (median 86).
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.
Classification
| Field | Value |
|---|---|
| Device name | Bulb, Inflation, For Endoscope |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCY clearance
Top FCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zutron Medical, LLC | 1 | 2010-02-22 |
| Biomedical Dynamics, Inc. | 1 | 1990-12-20 |
| CIVCO Medical Instruments Co., Inc. | 1 | 1990-06-11 |
Most recent FCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093718 | Zutron Medical, LLC | ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 | 2010-02-22 | 82 |
| K904376 | Biomedical Dynamics, Inc. | ANEROID BLOOD PRESSURE GAUGE | 1990-12-20 | 86 |
| K900016 | CIVCO Medical Instruments Co., Inc. | TRANS/R - FP(3) | 1990-06-11 | 160 |
Recalls for FCY devices
openFDA lists no recalls for product code FCY.
Frequently asked questions
What is FDA product code FCY?
FCY is the FDA product code for bulb, inflation, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FCY?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCY?
Across 3 cleared submissions the average was 109 days from receipt to decision (median 86).
Which companies have the most FCY clearances?
Zutron Medical, LLC (1); Biomedical Dynamics, Inc. (1); CIVCO Medical Instruments Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FCY
- Run a recall and safety report across every FCY manufacturer
- Watch product code FCY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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