Cleared Traditional

K172929 - Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath (FDA 510(k) Clearance)

K172929 · Boston Scientific Corporation · Gastroenterology & Urology device
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Jan 2018
Decision
107d
Days
-
Risk

K172929 is an FDA 510(k) clearance for the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sh.... Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on January 10, 2018 after a review of 107 days - within the typical 510(k) review window.

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 K172929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2017
Decision Date January 10, 2018
Days to Decision 107 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
23d faster than avg
Panel avg: 130d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -