510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081323Substantially Equivalent

Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818

BK Medical ApS, Herlev, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081323 is the FDA 510(k) clearance record for BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818, a class II device, cleared for B-K Medical Aps on under FDA product code FCG (Biopsy Needle). FDA records list 27 510(k) clearances for BK MEDICAL APS, from to . As of , FDA records show no recalls naming K081323.

Clearance record

Decision date
Received
(71 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
B-K Medical Aps Mileparken 34, Herlev, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

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