# K231407: StarFin

- Pathway: 510(k) (Traditional)
- Applicant: Premium Medical Technology, LLC
- Decided: Aug 29, 2023 after 106 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K993625 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193339: GTK Veress Needles, Guangzhou T.K Medical Instrument Co., Ltd. (2020) Summary page 4.
- K954853: Auto Suture Suture Closure, United States Surgical, A Division of Tyco Healthc (1995) Summary page 4.

## Indications for use
The StarFin device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum for laparoscopic procedures prior to the placement of trocars. The StarFin device is also used for suture capture, passing, externalization and internalization for wound closure after laparoscopic surgery.

Source page: https://510kreport.com/device/K231407
Methodology: https://510kreport.com/methodology