# K964123: Reusable Trocar with Sleeve (Common)

- Pathway: 510(k) (Traditional)
- Applicant: Pilling Weck Group
- Decided: Dec 12, 1996 after 58 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Core Dynamics Entree I: named in the summary without a submission number
- (no number) Access Surgical Access Single Use Trocar and Sleeve: named in the summary without a submission number
- (no number) Mahe Reusable Standard Trocar and Trumpet Valve Cannula: named in the summary without a submission number
- (no number) Mahe Safety Trocar: named in the summary without a submission number

## Indications for use
The Reusable Trocars and Cannula with Insufflation Ports are manual surgical instruments used to support a cut down(lap approach). The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry. The usage of this product is identical to previous devices, which have the same technological characteristics.

Source page: https://510kreport.com/device/K964123
Methodology: https://510kreport.com/methodology