510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K914941Substantially Equivalent

Simon Breast Lesion Localization Needle

Argon Medical Devices, Inc, Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914941 is the FDA 510(k) clearance record for SIMON BREAST LESION LOCALIZATION NEEDLE, a class I device, cleared for Manan Medical Products, Inc. on under FDA product code GDF (Guide, Needle, Surgical). FDA records list 64 510(k) clearances for ARGON MEDICAL DEVICES INC., from to . As of , FDA records show no recalls naming K914941.

Clearance record

Decision date
Received
(192 days to decision)
Product code
GDF Guide, Needle, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Manan Medical Products, Inc. 2200 Carlson Dr., Northbrook IL
510(k) summary
Statement
Third party review
No

Clearances, product code GDF

Trailing 12 months

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

FDA records show no clearances under product code GDF in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260