# K191295: Percutaneous Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Progressive Medical, Inc.
- Decided: Aug 6, 2019 after 84 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
Longest line of descent: 1 generation back to K951090 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951090: Introducer, Ranfac, Corp. (1995) Summary page 4.

## Indications for use
Introducer for Endoscopic/Laparoscopic procedures.

Source page: https://510kreport.com/device/K191295
Methodology: https://510kreport.com/methodology