510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K902177Substantially Equivalent

Manan Bone Biopsy Needle

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

K902177 is the FDA 510(k) clearance record for MANAN BONE BIOPSY NEEDLE, a class I device, cleared for Manan Medical Products, Inc. on under FDA product code GDM (Needle, Aspiration And Injection, Reusable). FDA records list 64 510(k) clearances for ARGON MEDICAL DEVICES INC., from to . As of , FDA records show no recalls naming K902177.

Clearance record

Decision date
Received
(113 days to decision)
Product code
GDM Needle, Aspiration And Injection, Reusable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Manan Medical Products, Inc. 2200 Carlson Dr., Northbrook IL
Third party review
No

Clearances, product code GDM

Trailing 12 months

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

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