510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K914874Substantially Equivalent

Manan Pro-Mag Automatic Biopsy Device

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

K914874 is the FDA 510(k) clearance record for MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE, a class II device, cleared for Manan Medical Products, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list 64 510(k) clearances for ARGON MEDICAL DEVICES INC., from to . As of , FDA records show no recalls naming K914874.

Clearance record

Decision date
Received
(112 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Manan Medical Products, Inc. 2200 Carlson Dr., Northbrook IL
510(k) summary
Statement
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to November 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260
November 20260