Trans/R - FP(3)
FDA 510(k) K900016 · CIVCO Medical Instruments Co., Inc.
510(k) numberK900016
Submission
- Device name
- Trans/R - FP(3)
- Applicant
- CIVCO Medical Instruments Co., Inc.
Kalona, IA, US - Received
- January 2, 1990
- Decision date
- June 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCY – Bulb, Inflation, For Endoscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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.
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Questions and answers
When was Trans/R - FP(3) cleared by the FDA?
Trans/R - FP(3) (K900016) received a 510(k) decision of Substantially Equivalent on June 11, 1990, 160 days after the submission was received.
What is the product code of K900016?
The FDA product code is FCY – Bulb, Inflation, For Endoscope, a Class I (low risk) device regulated under 21 CFR 876.1500.