# K032889: Optical Separator

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Oct 2, 2003 after 15 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 K990028 (1999). 2 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990028: Endopath Optiview Optical Surgical Obturator and Sleeve, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K012884: Dilating Tip Obturator, Applied Medical Resources Corp. (2002) Summary page 1.

## Most influential descendants
- K060096: Modular Trocar System (2006), 10 descendants of its own
- K083638: Fixation Trocars (2008), 4 descendants of its own
- K211577: SoftFix Balloon Trocar (2021), 2 descendants of its own
- K072674: Kii Trocar System (2007), 2 descendants of its own
- K041795: Modification to Optical Separator System (2004), 2 descendants of its own

## Indications for use
The Optical Separator 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.

Source page: https://510kreport.com/device/K032889
Methodology: https://510kreport.com/methodology