510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K852402Substantially Equivalent

Namic Homer Mammalok Needle/wire Localizer

North American Instrument Corp., NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852402 is the FDA 510(k) clearance record for NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER, a class I device, cleared for North American Instrument Corp. on under FDA product code FZX (Guide, Surgical, Instrument). FDA records list 28 510(k) clearances for North American Instrument Corp., from to . As of , FDA records show no recalls naming K852402.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FZX Guide, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
North American Instrument Corp.
Third party review
No

Clearances, product code FZX

Trailing 12 months

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

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