510(k) K093718
K093718 is an FDA 510(k) premarket notification submitted by Zutron Medical, LLC for the device "ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003". The FDA issued a decision of Substantially Equivalent on February 22, 2010. The device falls under product code FCY (Bulb, Inflation, For Endoscope), a Class I device regulated under 21 CFR 876.1500. Zutron Medical, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2010
- Date Received
- December 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bulb, Inflation, For Endoscope
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
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.