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510(k) K823418

HEYER-SCHUTE UNIVERSAL URETERAL STENT by American Hospital Supply Corp. — Product Code LJE

K823418 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "HEYER-SCHUTE UNIVERSAL URETERAL STENT". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
November 15, 1982
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 American Hospital Supply Corp.

  • K854739 — AMERICAN STERILE SURGICAL ABSORBENT TOWEL (December 27, 1985)
  • K854759 — AMERICAN STERILE MAYO STAND TRAY (December 17, 1985)
  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • K830546 — DOSIMETRIC RELEASE (May 25, 1983)
  • K822990 — CONVERTORS PRIMARY WOUND DRESSING II (April 12, 1983)
  • K830343 — CONTAINER W/PRIMING SOLUTION (March 17, 1983)
  • K830301 — STRATUS FLUOROMETRIC ENZYME IMMUN0- (February 25, 1983)
  • K822755 — LATEX PENROSE TUBING (January 21, 1983)
  • K822966 — CONVERTORS DISPOSABLE DRESSING SPONGE (November 5, 1982)
  • K822754 — EAR/ULCER SYRINGE (October 4, 1982)

Other clearances for product code LJE

  • K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit (July 3, 2025)
  • K222705 — Introducer Needle (May 22, 2023)
  • K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kit (March 10, 2022)
  • K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (December 17, 2020)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (July 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 (March 27, 2019)
  • K181713 — Ultraxx Nephrostomy Balloon Catheter Set (August 17, 2018)

FDA data resources