# K133845: 8MM Trocar Kit

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical
- Decided: Feb 19, 2014 after 63 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920110 (1992). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112358: Unimax Trocar System, Unimax Medical Systems, Inc. (2011) Summary page 4.

## Most influential descendants
- K181395: Universal Cannula Seal (5-12 mm) (2018), 4 descendants of its own
- K231358: Universal Seal (5-12 mm) (2023), 3 descendants of its own
- K241360: Universal Seal (5-12 mm) (2024), 2 descendants of its own
- K253978: Universal Seal (5-12 mm) (2026), 1 descendant of its own
- K261249: Universal Seal (5-12 mm) (2026), 0 descendants of its own

## Recalls of this device
- May 10, 2016 · Class II · Z-2038-2016: Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
- May 9, 2016 · Class II · Z-1836-2016: Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during

## Indications for use
The 8 mm Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

Source page: https://510kreport.com/device/K133845
Methodology: https://510kreport.com/methodology