510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K881697Substantially Equivalent

Breast Lesion Localization Needle

BD Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881697 is the FDA 510(k) clearance record for BREAST LESION LOCALIZATION NEEDLE, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K881697.

Clearance record

Decision date
Received
(148 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
Third party review
No

Clearances, product code IZH

Trailing 12 months

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

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