# K013611: Henke Sass Wolf Saphenous Vein Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Henke Sass Wolf of America, Inc.
- Decided: Feb 1, 2002 after 88 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K941967 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941967: HSW Laparoscope and Accessories, Henke-Sass, Wolf GmbH (1994) Summary page 1.
- (no number) Stryker Saphenous Vein Harvest Laparoscope: named in the summary without a submission number

## Indications for use
Intended for use in Endoscopic Saphenous Vein harvesting procedures.

Source page: https://510kreport.com/device/K013611
Methodology: https://510kreport.com/methodology