Cleared Traditional

K900016 - TRANS/R - FP(3) (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K900016 · CIVCO Medical Instruments Co., Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
160d
Days
Class 1
Risk

K900016 is an FDA 510(k) clearance for the TRANS/R - FP(3). Classified as Bulb, Inflation, For Endoscope (product code FCY), Class I - General Controls.

Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on June 11, 1990 after a review of 160 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all CIVCO Medical Instruments Co., Inc. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 130d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCY Bulb, Inflation, For Endoscope
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.