# K050163: Henke Sass Wolf of America Bariatric Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Henke Sass Wolf of America, Inc.
- Decided: Mar 24, 2005 after 58 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). 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)
- K941967: HSW Laparoscope and Accessories, Henke-Sass, Wolf GmbH (1994) Summary page 1.
- K993045: Bariatric Laparoscope, Model 367, Stryker Endoscopy (1999) Summary page 1.

## Most influential descendants
- K201198: S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable (2020), 0 descendants of its own

## Indications for use
The Henke Sass Wolf of America HSW Bariatric Laparoscope is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intra-abdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and liver. Bariatric laparoscopes are intended to be used to perform surgical procedures on morbidly obese segments of the patient population.

Source page: https://510kreport.com/device/K050163
Methodology: https://510kreport.com/methodology