# K200517: Standard Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Standard Bariatrics
- Decided: Apr 9, 2020 after 38 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: 4 generations back to K990028 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060096: Modular Trocar System, Applied Medical Resources Corp. (2006) Summary page 4.
- K083638: Fixation Trocars, Applied Medical Resources Corp. (2008) Summary page 4.

## Indications for use
The Standard Trocar is a sterile, single-use device consisting of an obturator, a cannula, a 5mm adapter and introducer sheath. This system is indicated for use in general and abdominal 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/K200517
Methodology: https://510kreport.com/methodology