510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895897Substantially Equivalent

Manan Prostatic Biopsy Needle

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

K895897 is the FDA 510(k) clearance record for MANAN PROSTATIC BIOPSY NEEDLE, a class II device, cleared for Manan Medical Products, Inc. on under FDA product code FCG (Biopsy Needle). FDA records list 64 510(k) clearances for ARGON MEDICAL DEVICES INC., from to . As of , FDA records show no recalls naming K895897.

Clearance record

Decision date
Received
(12 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Manan Medical Products, Inc. 2200 Carlson Dr., Northbrook IL
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

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