510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944942Substantially Equivalent

Breast Lesion Localization Needle

Promedical, Ltd., Wyckoff NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944942 is the FDA 510(k) clearance record for BREAST LESION LOCALIZATION NEEDLE, a class I device, cleared for Promedical , Ltd. on under FDA product code GDF (Guide, Needle, Surgical). FDA records list 5 510(k) clearances for Promedical , Ltd., from to . As of , FDA records show no recalls naming K944942.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GDF Guide, Needle, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Promedical , Ltd. 240 Braen Ave., Wyckoff NJ
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDF, 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