Cleared Traditional

K160077 - RetroPerc Flexible Ureteroscopy-Guided ...

K160077 · Jbw7 Innovations, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
180d
Days
-
Risk

K160077 is an FDA 510(k) clearance for the RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Jbw7 Innovations, LLC (Southfield, US). The FDA issued a Cleared decision on July 12, 2016 after a review of 180 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.

View all Jbw7 Innovations, LLC devices

FDA 510(k) Submission Details - K160077

510(k) Number K160077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2016
Decision Date July 12, 2016
Days to Decision 180 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
50d slower than avg
Panel avg: 130d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

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