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510(k) K020714

RUSCH FLONEIL; FLOCATH INTROGEL by Rusch Intl. — Product Code GBM

K020714 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH FLONEIL; FLOCATH INTROGEL". The FDA issued a decision of Substantially Equivalent on July 1, 2002. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Rusch Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2002
Date Received
March 5, 2002
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 Rusch Intl.

  • K033023 — INTERMITTENT URETHRAL CATHETERS (December 23, 2003)
  • K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM (June 30, 2003)
  • K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (June 17, 2003)
  • K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS (March 28, 2003)
  • K023964 — RUSCH MICROLARYNGEAL TUBE (December 23, 2002)
  • K021540 — RUSCH EDGAR TUBE (August 1, 2002)
  • K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (July 23, 2002)
  • K010797 — RUSCH MILLER-ABBOTT TUBE (February 26, 2002)
  • K010798 — RUSCH CANTOR TUBE (February 26, 2002)
  • K013872 — RUSCH MEMORY BAG (February 12, 2002)

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