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510(k) K160077

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set by Jbw7 Innovations, LLC — Product Code LJE

K160077 is an FDA 510(k) premarket notification submitted by Jbw7 Innovations, LLC for the device "RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set". The FDA issued a decision of Substantially Equivalent on July 12, 2016. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2016
Date Received
January 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

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FDA data resources