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510(k) K011121

RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS by Rusch Intl. — Product Code LJE

K011121 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS". The FDA issued a decision of Substantially Equivalent on Nov 16, 2001. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Rusch Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 16, 2001
Date Received
Apr 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Rusch Intl.

  • K033023 — INTERMITTENT URETHRAL CATHETERS (Dec 23, 2003)
  • K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM (Jun 30, 2003)
  • K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (Jun 17, 2003)
  • K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS (Mar 28, 2003)
  • K023964 — RUSCH MICROLARYNGEAL TUBE (Dec 23, 2002)
  • K021540 — RUSCH EDGAR TUBE (Aug 1, 2002)
  • K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (Jul 23, 2002)
  • K020714 — RUSCH FLONEIL; FLOCATH INTROGEL (Jul 1, 2002)
  • K010798 — RUSCH CANTOR TUBE (Feb 26, 2002)
  • K010797 — RUSCH MILLER-ABBOTT TUBE (Feb 26, 2002)

Other clearances for product code LJE

  • K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit (Jul 3, 2025)
  • K222705 — Introducer Needle (May 22, 2023)
  • K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kit (Mar 10, 2022)
  • K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (Dec 17, 2020)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (Jan 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (Dec 16, 2019)
  • K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (Jul 16, 2019)
  • K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Tro (May 17, 2019)
  • K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (Mar 27, 2019)
  • K181713 — Ultraxx Nephrostomy Balloon Catheter Set (Aug 17, 2018)

FDA data resources