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510(k) K041416

EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER by Deroyal — Product Code EYC

K041416 is an FDA 510(k) premarket notification submitted by Deroyal for the device "EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on July 2, 2004. The device falls under product code EYC (Catheter, Upper Urinary Tract), a Class II device regulated under 21 CFR 876.5130. Deroyal has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2004
Date Received
May 27, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Upper Urinary Tract
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Deroyal

  • K033057 — DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE (November 20, 2003)
  • K031408 — DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) (October 15, 2003)
  • K030908 — DEROYAL SURGICAL DRAPES BACKTABLE COVER (August 11, 2003)
  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)

Other clearances for product code EYC

  • K200757 — Foley Catheter with Temperature Sensor (October 15, 2020)
  • K061918 — FOLEY CATHETERS WITH TEMPERATURE PROBE (August 18, 2006)
  • K925790 — EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S (May 17, 1993)
  • K890310 — STERILE FOLEY CATHETER (November 30, 1989)

FDA data resources