510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895420Substantially Equivalent

Suction Biopsy Instrument

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

K895420 is the FDA 510(k) clearance record for SUCTION BIOPSY INSTRUMENT, a class II device, cleared for Mill-Rose Laboratory on under FDA product code FCK (Instrument, Biopsy, Suction). FDA records list 46 510(k) clearances for Mill-Rose Laboratory, from to . As of , FDA records show no recalls naming K895420.

Clearance record

Decision date
Received
(161 days to decision)
Product code
FCK Instrument, Biopsy, Suction
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mill-Rose Laboratory 7310 Corporate Blvd., Mentor OH
Third party review
No

Clearances, product code FCK

Trailing 12 months

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

FDA records show no clearances under product code FCK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCK, 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