510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792316Substantially Equivalent

Trotex II Screw Needle Biopsy Instr. Set

Ursus Konsult AB, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792316 is the FDA 510(k) clearance record for TROTEX II SCREW NEEDLE BIOPSY INSTR. SET, a class I device, cleared for Ursus Konsult AB on under FDA product code GEE (Brush, Biopsy, General & Plastic Surgery). FDA records list one 510(k) clearance for Ursus Konsult AB. As of , FDA records show no recalls naming K792316.

Clearance record

Decision date
Received
(32 days to decision)
Product code
GEE Brush, Biopsy, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ursus Konsult AB 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GEE

Trailing 12 months

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

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