# K012198: Gibbons Sterile Trocar Kits

- Pathway: 510(k) (Special)
- Applicant: Gibbons Surgical Corp.
- Decided: Aug 9, 2001 after 27 days
- Product code: FBQ (Trocar, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 (2008), 17 descendants of its own
- K130943: Aigis RX R PM/ Aigis RX R Icd (2013), 14 descendants of its own
- K131007: Aigis RX N Medium; Aigis RX N Large (2013), 6 descendants of its own
- K132699: Aigis RX N (Medium), Aigis RX N (Large) (2013), 5 descendants of its own
- K142611: TYRX Neuro Absorbable Antibacterial Envelope (2014), 4 descendants of its own

## Indications for use
The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/endoscopic surgery under the guidance of a physician.

Source page: https://510kreport.com/device/K012198
Methodology: https://510kreport.com/methodology