# K990028: Endopath Optiview Optical Surgical Obturator and Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Apr 1, 1999 after 86 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
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K032889: Optical Separator (2003), 13 descendants of its own
- K060096: Modular Trocar System (2006), 10 descendants of its own
- K083638: Fixation Trocars (2008), 4 descendants of its own
- K043253: Vanguard Reprocessed Dilating Tip and Blunt Trocars (2005), 3 descendants of its own
- K211577: SoftFix Balloon Trocar (2021), 2 descendants of its own

## Indications for use
The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve has applications in abdominal, gynecologic, and thoracic minimally invasive surgical procedures as well as endoscopic surgery of superficial veins and fascia of the lower extremities to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The trocar may be used without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K990028
Methodology: https://510kreport.com/methodology