510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904079Substantially Equivalent

Bard Uterine Manipulator

C.R. Bard Inc, Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904079 is the FDA 510(k) clearance record for BARD UTERINE MANIPULATOR, a class II device, cleared for C.R. Bard, Inc. on under FDA product code LKF (Cannula, Manipulator/Injector, Uterine). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K904079.

Clearance record

Decision date
Received
(155 days to decision)
Product code
LKF Cannula, Manipulator/Injector, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
C.R. Bard, Inc. 5 Federal St., Billerica MA
Third party review
No

Clearances, product code LKF

Trailing 12 months
1 clearance under product code LKF in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LKF, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260