SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE— 510(k) K895594

Clearance details

Applicant

Go Medical Industries Pty. , Ltd.

Product code

Code GDM

Device class

Class 1

Regulation

21 CFR 878.4800

Advisory panel

General, Plastic Surgery

Date received

1989-09-15

Decision date

1989-10-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Subiaco, Perth, AU

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• K953064 — BIOACCESS MARROW HARVEST SYSTEM1995-08-07
• K936207 — ENDO-NEEDLE INSTRUMENT1994-06-16

• K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS2001-06-06
• K002803 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT2000-12-27
• K000263 — GO MEDICAL BALLOON INFUSION SYSTEM2000-05-09
• K910007 — SPRINGFUSOR 10R1993-11-02
• K900336 — V SET1990-10-04

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →