# K971334: Pilling Weck Secondary Flexible Sleeve with Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Pilling Weck Group
- Decided: Jun 11, 1997 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
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 Pilling Weck Secondary Flexible Sleeve with Cap and Trocar are manual surgical instruments used to support -a cut down (lap approach) on sgcondary puricture placement. 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 flexible sleeve. Ogce the Trocar is removed, the port of entry provided by the sleeve through the cap, is used with manual instruments, laproscopes, and probes.

Source page: https://510kreport.com/device/K971334
Methodology: https://510kreport.com/methodology