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510(k) K895594

SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE by Go Medical Industries Pty. , Ltd. — Product Code GDM

K895594 is an FDA 510(k) premarket notification submitted by Go Medical Industries Pty. , Ltd. for the device "SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Go Medical Industries Pty. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
September 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Go Medical Industries Pty. , Ltd.

  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K002803 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT (December 27, 2000)
  • K000263 — GO MEDICAL BALLOON INFUSION SYSTEM (May 9, 2000)
  • K910007 — SPRINGFUSOR 10R (November 2, 1993)
  • K900336 — V SET (October 4, 1990)
  • K890400 — MODIFIED URINARY CATHETER INTRODUCER (UCI) (September 12, 1989)
  • K891465 — OBSTETRIC CUP (MODIFICATION) (May 11, 1989)
  • K885283 — ASPIRATING AND IRRIGATING CYSTS NEEDLES (March 22, 1989)
  • K850758 — AMNIGLOVE & AMNICOT (April 15, 1985)
  • K840008 — O'NEIL OBSTETRIC CUP (April 25, 1984)

Other clearances for product code GDM

  • K071732 — MARROWMINER (September 24, 2007)
  • K971114 — BIOACCESS MARROW HARVEST SYSTEM (June 3, 1997)
  • K953082 — ILIAC CREST BONE MARROW ASPIRATION NEEDLE (September 22, 1995)
  • K953064 — BIOACCESS MARROW HARVEST SYSTEM (August 7, 1995)
  • K936207 — ENDO-NEEDLE INSTRUMENT (June 16, 1994)
  • K930160 — ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE (July 6, 1993)
  • K923872 — BONE MARROW BIOPSY SYSTEM (December 15, 1992)
  • K915572 — BECTON DICKINSON MODIFIED MENGHINI NEEDLE (February 3, 1992)
  • K904667 — NA NEEDLES (December 12, 1990)
  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)

FDA data resources