Home / 510(k) Clearances / K935630

510(k) K935630

NORTA by Beiersdorf, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1994
Date Received
November 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Beiersdorf, Inc.

  • K090921 — ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, (December 18, 2009)
  • K032463 — CURAD SILVER BANDAGE (February 10, 2004)
  • K032462 — CURAD SILVER ACTIVE GEL BANDAGE (February 10, 2004)
  • K024057 — CURAD SCAR THERAPY (June 18, 2003)
  • K022645 — CURAD (November 5, 2002)
  • K952526 — CUTINOVA CAVITY (August 14, 1995)
  • K943363 — CUTIPLAST STERIL (March 15, 1995)
  • K944581 — CUTINOVA THIN WOUND DRESSING (December 2, 1994)
  • K940378 — COVERLET ADHESIVE DRESSING (July 29, 1994)
  • K925630 — ELASTOPLAST HEAT PLASTER (February 25, 1994)

Other clearances for product code EZL

  • K252537 — Rusch SoftSimplastic Foley Catheters (January 20, 2026)
  • K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter) (June 16, 2025)
  • K241424 — InnoCare Specialty Foley Catheter (September 18, 2024)
  • K232469 — Rüsch Latex Gold Foley Catheter (August 1, 2024)
  • K240057 — TraumaGuard Intra-abdominal Pressure Sensing System (April 17, 2024)
  • K233411 — Folysil Silicone Catheter (April 15, 2024)
  • K233013 — 2-Way 100% Silicone Cleartract Catheter (January 23, 2024)
  • K212077 — Teleflex Rusch SoftSimplastic Foley Catheters (July 27, 2023)
  • K231101 — Flume Catheter (June 29, 2023)
  • K221020 — Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accu (January 13, 2023)