KURZ SILICONE STRIPS - Sf-1 Bs

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

510(k) Number

K033796 ↗

FDA Product Code

KHJ

Models / Variants

Sf-1

Sf-1W

Sf-1 Bs

Device Class

Class II

Regulation

21 CFR Part 874.3620

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Kurz Upper Eyelid Implant- Platinum/Iridium, Models Regular 4007 003-007, Special 4007 002, 4007 008-010

  Class II

  FDA 510(k) K011115 Active Cleared 2 May 2001

• Clip Piston Awengen, Model# 1006 805 - 1006 861

  Class II

  CE/MDD FDA 510(k) K021479 Active Cleared 21 May 2002

• Nitiflex Stapes Prosthesis

  Class II

  CE/MDD FDA 510(k) K130512 Active Cleared 2 Dec 2013

• Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire

  Class II

  CE/MDD FDA 510(k) K071150 Active Cleared 12 Dec 2007

• Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10

  Class II

  FDA 510(k) K000127 Active Cleared 12 Apr 2000

• Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T)

  Class II

  FDA 510(k) K973226 Active Cleared 4 Nov 1997

See all devices from Heinz Kurz GmbH Medizintechnik →

• What is the Kurz Silicone Strip used for?

  The Kurz Silicone Strip is used in the external ear canal following middle ear surgery to support healing and maintain canal patency. It is made of medical-grade silicone elastomer and is designed to be placed without intraoperative shaping due to its pre-cut dimensions.

• How is the Kurz Silicone Strip supplied and is it reusable?

  The device is supplied sterile and pre-cut to size (0.12 x 45 x 6 mm) in models SF-1, SF-1W, and SF-1 BS. It is intended for single-use only and must not be reused, as re-sterilization or reprocessing is not validated and could compromise safety or performance.

• What sizes and models are available for the Kurz Silicone Strip?

  The Kurz Silicone Strip is available in three models: SF-1, SF-1W, and SF-1 BS. All models are pre-cut to the same dimensions of 0.12 mm thickness, 45 mm width, and 6 mm length, eliminating the need for intraoperative trimming or shaping.

• What materials is the Kurz Silicone Strip made from and how is it classified?

  The device is made of medical-grade silicone elastomer and is classified under FDA regulation 874.3620 as a Polymer, Ent Synthetic-polyamide (Mesh Or Foil Material). This classification reflects its material composition and intended use in ear, nose, and throat applications.

• What regulatory pathway was used for the Kurz Silicone Strip?

  The Kurz Silicone Strips received FDA 510(k) clearance (K033796) as substantially equivalent to a predicate device. The clearance was granted through the traditional 510(k) pathway, with a decision date of January 30, 2004, based on submission received December 5, 2003.