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510(k) K946282

UNIVERSAL URETHRAL CATHETER by Louisville Laboratories, Inc. — Product Code EZC

K946282 is an FDA 510(k) premarket notification submitted by Louisville Laboratories, Inc. for the device "UNIVERSAL URETHRAL CATHETER". The FDA issued a decision of Substantially Equivalent on March 31, 1995. The device falls under product code EZC (Catheter, Coude), a Class II device regulated under 21 CFR 876.5130. Louisville Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
December 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Coude
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Louisville Laboratories, Inc.

  • K980123 — CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET (March 9, 1998)
  • K971796 — LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS (August 12, 1997)
  • K971802 — VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION (July 30, 1997)
  • K971791 — VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION (July 30, 1997)
  • K971797 — LAPAROSCOPIC BLADDER NECK SUSPENSION KIT (July 22, 1997)
  • K971801 — LAPAROTOMY BLADDER NECK SUSPENSION KIT (July 22, 1997)
  • K963076 — LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY (April 4, 1997)
  • K960882 — CONTROL SYRINGE (July 8, 1996)
  • K955535 — LOUISVILLE LABS OXYGEN HEAD TENT (July 1, 1996)
  • K932979 — EXTERNAL STABILITY PAD (November 2, 1993)

Other clearances for product code EZC

  • K222279 — Rusch Intermittent Urethral Catheters (August 29, 2022)
  • K173596 — Rusch Intermittent Urethral Catheters (January 29, 2018)
  • K913341 — BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER (January 27, 1992)
  • K910846 — BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF (August 16, 1991)
  • K910197 — HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS (August 9, 1991)
  • K910195 — BARD HYDROGEL-COATED FOLEY CATHETERS (August 9, 1991)

FDA data resources