# K201198: S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew
- Decided: Jul 17, 2020 after 74 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: 2 generations back to K941967 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941541: HSV Laparoscopy Set, Henke Sass Wolf of America, Inc. (1994) Summary page 5.
- K050163: Henke Sass Wolf of America Bariatric Laparoscope, Henke Sass Wolf of America, Inc. (2005) Summary page 5.

## Indications for use
The Smith & Nephew Laparoscopes are indicated for use in illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder and Liver. Smith & Nephew Bariatric Laparoscopes are indicated for illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder and Liver.

Source page: https://510kreport.com/device/K201198
Methodology: https://510kreport.com/methodology