# K961463: Heartport Thoracic Surgical Trocars: (Tost-4-3, Tostl-6-3, Ton-4-2 and Tonl-6-2

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Oct 8, 1996 after 174 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) U.S. Surgical - Auto Suture Thoracoport 11.5 mm Disposable Trocar: named in the summary without a submission number
- (no number) Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic: named in the summary without a submission number
- (no number) Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator: named in the summary without a submission number
- (no number) Snowden-Pencer - Reusable Thora-Port: named in the summary without a submission number
- (no number) Deknatel - Gabby-Frater Suture Guide: named in the summary without a submission number

## Indications for use
Heartport Thoracic Surgical Trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. The Heartport Thoracic Trocar allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiac surgery procedures. The trocar cannula may also be used for suture organization.

Source page: https://510kreport.com/device/K961463
Methodology: https://510kreport.com/methodology