510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895594Substantially Equivalent

Single Lumen O'neil Aspiration & Irrigation Needle

Go Medical Industries Pty., Ltd., Subiaco, Perth, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895594 is the FDA 510(k) clearance record for SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE, a class I device, cleared for Go Medical Industries Pty. , Ltd. on under FDA product code GDM (Needle, Aspiration And Injection, Reusable). FDA records list 11 510(k) clearances for Go Medical Industries Pty. , Ltd., from to . As of , FDA records show no recalls naming K895594.

Clearance record

Decision date
Received
(21 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
Go Medical Industries Pty. , Ltd. 200 Churchill Ave., Subiaco, Perth, AU
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDM, 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