K900016 is an FDA 510(k) clearance for the TRANS/R - FP(3). This device is classified as a Bulb, Inflation, For Endoscope (Class I - General Controls, product code FCY).
Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on June 11, 1990, 160 days after receiving the submission on January 2, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. 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) Number | K900016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1990 |
| Decision Date | June 11, 1990 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FCY — Bulb, Inflation, For Endoscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1500 |
| 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. |