510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962425Substantially Equivalent

Bonopty Coaxial Bone Biopsy System with Eccentric Drill(10-1072,3,4)

Radi Medical Systems AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962425 is the FDA 510(k) clearance record for BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4), a class I device, cleared for Radi Medical Systems AB on under FDA product code GAA (Needle, Aspiration And Injection, Disposable). FDA records list 24 510(k) clearances for Radi Medical Systems AB, from to . As of , FDA records show no recalls naming K962425.

Clearance record

Decision date
Received
(79 days to decision)
Product code
GAA Needle, Aspiration And Injection, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Radi Medical Systems AB Palmbladsgatan 10, Uppsala, SE
510(k) summary
Summary
Third party review
No

Clearances, product code GAA

Trailing 12 months

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

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