510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850489Substantially Equivalent

Endosopic Stene Manipulating Balloon

Mill-Rose Laboratory, Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850489 is the FDA 510(k) clearance record for ENDOSOPIC STENE MANIPULATING BALLOON, a class II device, cleared for Mill-Rose Laboratory on under FDA product code LQR (Dislodger, Stone, Biliary). FDA records list 46 510(k) clearances for Mill-Rose Laboratory, from to . As of , FDA records show no recalls naming K850489.

Clearance record

Decision date
Received
(73 days to decision)
Product code
LQR Dislodger, Stone, Biliary
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mill-Rose Laboratory 7310 Corporate Blvd., Mentor OH
Third party review
No

Clearances, product code LQR

Trailing 12 months
1 clearance under product code LQR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LQR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260