# K041795: Modification to Optical Separator System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Sep 14, 2004 after 74 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990028 (1999). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032889: Optical Separator, Applied Medical Resources (2003) Summary page 1.
- K963359: Insufflation Needle, Applied Medical Resources (1996) Summary page 1.

## Most influential descendants
- K111002: Reprocessed Endoscopic Trocars (2011), 0 descendants of its own
- K063788: Reprocessed Endoscopic Trocars and Cannulas (2007), 0 descendants of its own

## Recalls of this device
- Jan 28, 2019 · Class II · Z-1959-2019: The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.

## Indications for use
The Optical Separator System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

Source page: https://510kreport.com/device/K041795
Methodology: https://510kreport.com/methodology