510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K070091Substantially Equivalent

Coaxial Bone and Vertebral Body Biopsy Needle Model# Jbc1213, Jbc1208

Medtronic, Inc., Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070091 is the FDA 510(k) clearance record for COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208, a class II device, cleared for Cardinal Health, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K070091.

Clearance record

Decision date
Received
(98 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cardinal Health, Inc. 1430 Waukegan Rd.- Mpkb-3b, Mcgaw Park IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNW

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