Bulb, Inflation, For Endoscope
The Inflation Bulb for Endoscope (product code FCY) is an accessory device that pressurizes the interior of an endoscope to facilitate leak testing; the user detects leaks by immersing the endoscope in water and observing for air bubbles. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.
Basic Information
- Product Code
- FCY
- Device Class
- FDA class 1
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093718 | ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 | Feb 22, 2010 | Substantially Equivalent | ZUTRON MEDICAL LLC |
| K904376 | ANEROID BLOOD PRESSURE GAUGE | Dec 20, 1990 | Substantially Equivalent | BIOMEDICAL DYNAMICS, INC. |
| K900016 | TRANS/R - FP(3) | Jun 11, 1990 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.