# K963815: Reusable Trocar with Sleeve (Common)

- Pathway: 510(k) (Traditional)
- Applicant: Pilling Weck Group
- Decided: Nov 5, 1996 after 43 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) Apple Medical Hunt Reich Secondary Trocar: 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

## Indications for use
The Reusable Trocar and Sleeve are manual surgical instruments used to support a “tut down(lap approach) on secondary puncture placement. The trocar is used in Endoscopic Surgery(Abdominal 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/K963815
Methodology: https://510kreport.com/methodology