NORTA

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K935630 ↗

FDA Product Code

EZL

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Luekoflex Surgical Tape

  Class I

  FDA 510(k) K923404 Active Cleared 9 Sep 1992

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  Class II

  FDA 510(k) K090921 Active Cleared 18 Dec 2009

• Acrylastic

  Class I

  FDA 510(k) K921759 Active Cleared 10 Aug 1992

• Cutinova(R) Plus on Vascular Stasis Ulcers

  Unclassified

  FDA 510(k) K885279 Active Cleared 13 Jun 1989

• Leukosilk(Tm) Surgical Tape

  Class I

  FDA 510(k) K896891 Active Cleared 9 Feb 1990

• Curad Silver Active Gel Bandage

  Unclassified

  FDA 510(k) K032462 Active Cleared 10 Feb 2004

See all devices from Beiersdorf AG →

• What is the NORTA catheter used for?

  The NORTA is a retention type catheter with balloon functionality designed specifically for use in gastroenterology and urology procedures. It is manufactured by Beiersdorf, Inc.

• Is the NORTA catheter reusable or single-use?

  The NORTA catheter is supplied as a single-use product and should not be reused for patient safety reasons. It is not MRI compatible and should be stored at room temperature.

• What regulatory approvals does the NORTA catheter have?

  The NORTA catheter has FDA 510(k) clearance with the product code EZL. It was cleared in 1994 and is classified as substantially equivalent to predicate devices in the gastroenterology and urology fields.

• How is the NORTA catheter supplied and stored?

  The NORTA catheter is supplied as a single-use product and should be stored at room temperature. It is not MRI compatible, so it should not be used in MRI environments.