510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K160077Substantially Equivalent

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set

Jbw7 Innovations, LLC, Southfield MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160077 is the FDA 510(k) clearance record for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set, cleared for Jbw7 Innovations, LLC on under FDA product code LJE (Catheter, Nephrostomy). FDA records list one 510(k) clearance for Jbw7 Innovations, LLC. As of , FDA records show no recalls naming K160077.

Clearance record

Decision date
Received
(180 days to decision)
Product code
LJE Catheter, Nephrostomy
Device class
Unclassified
Review panel
Unknown
Applicant
Jbw7 Innovations, LLC 22200 W. 11 Mile Rd., # 4182, Southfield MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJE

Trailing 12 months

FDA records hold no clearances under product code LJE in the trailing twelve months.

FDA records show no clearances under product code LJE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260