510(k) K900016
K900016 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "TRANS/R - FP(3)". The FDA issued a decision of Substantially Equivalent on June 11, 1990. The device falls under product code FCY (Bulb, Inflation, For Endoscope), a Class I device regulated under 21 CFR 876.1500. CIVCO Medical Instruments Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1990
- Date Received
- January 2, 1990
- 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.