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510(k) K011055

THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS by Go Medical Industries Pty. , Ltd. — Product Code FCM

K011055 is an FDA 510(k) premarket notification submitted by Go Medical Industries Pty. , Ltd. for the device "THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS". The FDA issued a decision of Substantially Equivalent on June 6, 2001. The device falls under product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)), a Class II device regulated under 21 CFR 876.5130. Go Medical Industries Pty. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
April 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Go Medical Industries Pty. , Ltd.

  • 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)
  • K895594 — SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE (October 6, 1989)
  • 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 FCM

  • K254076 — BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (May 29, 2026)
  • K250891 — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Cathete (June 6, 2025)
  • K223821 — Self-Cath Closed System (August 2, 2023)
  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (June 1, 2007)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)

FDA data resources