# K964450: Secondary Trocar and Sleeve with Insufflation Port

- Pathway: 510(k) (Traditional)
- Applicant: Pilling Weck Group
- Decided: Jan 10, 1997 after 65 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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 II: 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) United States Surgical Acute Suture Surgiport™ Disposable Surgical Trocar and Cannula with Insufflation Port: named in the summary without a submission number
- (no number) Karl Stortz Trocars and Cannula with Insufflation Ports: named in the summary without a submission number

## Most influential descendants
- K081398: Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories (2009), 0 descendants of its own
- K993653: Micro-France Trocars and Accessories (2000), 0 descendants of its own

## Indications for use
The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary 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/K964450
Methodology: https://510kreport.com/methodology