# K112358: Unimax Trocar System

- Pathway: 510(k) (Traditional)
- Applicant: Unimax Medical Systems, Inc.
- Decided: Oct 17, 2011 after 62 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 K920110 (1992). 3 ancestors in all.
16 later devices descend from it; 6 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)
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar, Ethicon Endo-Surgery, Inc. (2003) Summary page 2.
- K971475: Shielded Surgical Trocar, Ethicon Endo-Surgery, Inc. (1997) Summary page 2.
- K920110: Endopath Disposable Thoracic Trocar Sleeve, ETHICON, Inc. (1992) Summary page 2.

## Most influential descendants
- K133845: 8MM Trocar Kit (2014), 6 descendants of its own
- K141594: Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar (2015), 5 descendants of its own
- 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

## Indications for use
The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocer, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for cndoscobic instruments.

Source page: https://510kreport.com/device/K112358
Methodology: https://510kreport.com/methodology