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510(k) K890400

MODIFIED URINARY CATHETER INTRODUCER (UCI) by Go Medical Industries Pty. , Ltd. — Product Code KOD

K890400 is an FDA 510(k) premarket notification submitted by Go Medical Industries Pty. , Ltd. for the device "MODIFIED URINARY CATHETER INTRODUCER (UCI)". The FDA issued a decision of Substantially Equivalent on September 12, 1989. The device falls under product code KOD (Catheter, Urological), 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
September 12, 1989
Date Received
January 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
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)
  • K895594 — SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE (October 6, 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 KOD

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)

FDA data resources