# K033796: Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz GmbH Medizintechnik
- Decided: Jan 30, 2004 after 56 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974653 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974653: Silicone Elastomer Sheeting, Specialty Surgical Products, Inc. (1998) Summary page 1.
- K022223: Aart Silicone Sheeting, Aesthetic and Reconstructive Technologies, Inc. (2002) Summary page 3.

## Most influential descendants
- K260266: Tympendi™ (810) (2026), 0 descendants of its own

## Indications for use
KURZ Silicone Strips are designed to temporarily cover the tympanic membrane after surgical procedures in the middle ear.

Source page: https://510kreport.com/device/K033796
Methodology: https://510kreport.com/methodology