Cleared Traditional

K191715 - Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191715 · STERIS Corporation · Gastroenterology & Urology device
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Jan 2020
Decision
215d
Days
Class 2
Risk

K191715 is an FDA 510(k) clearance for the Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile. Classified as Endoscopic Storage Cover (product code OCU), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 27, 2020 after a review of 215 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.

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Submission Details

510(k) Number K191715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date January 27, 2020
Days to Decision 215 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 130d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCU Endoscopic Storage Cover
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Protect Delicate Parts Of The Endoscope During Transport And Storage. May Also Be Used To Protect During Sterilization.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.