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510(k) K915751

URETEROMAT 4400 by F.M. Wiest USA, Inc. — Product Code EZN

K915751 is an FDA 510(k) premarket notification submitted by F.M. Wiest USA, Inc. for the device "URETEROMAT 4400". The FDA issued a decision of Substantially Equivalent on April 24, 1992. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. F.M. Wiest USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1992
Date Received
December 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

Other clearances by F.M. Wiest USA, Inc.

  • K921871 — HYSTEROMAT(TM) 3700 (December 15, 1994)
  • K920574 — CAMSYS 6300 (February 17, 1993)
  • K920575 — MERKUR 4000 (July 23, 1992)
  • K911844 — HYSTEROFLATOR 1500 (November 21, 1991)
  • K912071 — SPACE(TM) 7500 (July 9, 1991)
  • K910883 — LAPAROFLATOR ELECTRONIC 3509 (March 29, 1991)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K871181 — ARTHROCOMBI 5003 (September 29, 1987)
  • K871180 — ARTHRO AUTOMAT 5002 (September 29, 1987)
  • K865066 — ARTHROFLATOR (April 20, 1987)

Other clearances for product code EZN

  • K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter (May 22, 2025)
  • K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz (May 5, 2023)
  • K201007 — In-Ka Ureteral Balloon Dilatation Catheter (June 11, 2020)
  • K190612 — EQUINOX Balloon Dilatation Catheter (December 6, 2019)
  • K173654 — Ureteral Dilator Sets, Ureteral Dilators (July 17, 2018)
  • K180756 — Safety Wire Guide Introducer (May 24, 2018)
  • K180028 — Cook 810 Set, Desilets-Hoffman Introducer Set (May 2, 2018)
  • K172588 — Balloon Catheter and Balloon Ureteral Dilator Set (April 19, 2018)
  • K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators (August 17, 2017)
  • K132181 — GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER (October 21, 2013)

FDA data resources