510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850605Substantially Equivalent

Radi-Biopsy Device

Radiplast AB, Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850605 is the FDA 510(k) clearance record for RADI-BIOPSY DEVICE, a class II device, cleared for Radiplast AB on under FDA product code KNW (Instrument, Biopsy). FDA records list one 510(k) clearance for Radiplast AB. As of , FDA records show no recalls naming K850605.

Clearance record

Decision date
Received
(175 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Radiplast AB Attorney & Counselor At Law, Kalamazoo MI
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260