Cleared Traditional

K172358 - Instalief (FDA 510(k) Clearance)

K172358 · Privi Medical Pte, Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 2018
Decision
160d
Days
-
Risk

K172358 is an FDA 510(k) clearance for the Instalief. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Privi Medical Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on January 10, 2018 after a review of 160 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 K172358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2017
Decision Date January 10, 2018
Days to Decision 160 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
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 LKX Device, Thermal, Hemorrhoids
Device Class -