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510(k) K031409

URINARY CATHETERS by Promedic, Inc. — Product Code GBM

K031409 is an FDA 510(k) premarket notification submitted by Promedic, Inc. for the device "URINARY CATHETERS". The FDA issued a decision of Substantially Equivalent on June 17, 2003. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Promedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2003
Date Received
May 5, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Promedic, Inc.

  • K131889 — EUM 100PRO (April 23, 2014)
  • K112318 — CLEARPATH 24 (June 29, 2012)
  • K072756 — NON-IV ADAPTER FOR INFANT NG TUBE (December 19, 2007)
  • K060497 — BABYAIR (July 11, 2006)
  • K060842 — REVJET TURBO (June 21, 2006)
  • K052903 — PEDIATRIC FEEDING TUBE (November 9, 2005)
  • K024190 — FENESTRATED INFUSION CATHETER (March 17, 2003)
  • K023579 — GAS SAMPLING LINES (January 28, 2003)
  • K020005 — INFANT FEEDING TUBES (July 16, 2002)
  • K970102 — FILTER (June 24, 1997)

Other clearances for product code GBM

  • K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic In (March 5, 2025)
  • K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (June 22, 2022)
  • K211436 — Intermittent Catheter (Not Finalized) (January 27, 2022)
  • K200820 — SpeediCath Compact Set (November 13, 2020)
  • K192904 — SpeediCath Compact Set (November 2, 2020)
  • K200142 — SpeediCath Soft (July 30, 2020)
  • K200134 — Jimushi Sterile Urethral Catheter for single use (June 1, 2020)
  • K191512 — LotusCatheter (Lotus No Balloon Catheter) (May 21, 2020)
  • K192577 — Actreen Hi-Lite Intermittent Urinary Catheters (May 7, 2020)
  • K193148 — VaPro Plus Pocket, VaPro Plus (December 13, 2019)

FDA data resources