# K103200: Propep Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Apr 12, 2011 after 162 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K013040 (2001). 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)
- K013040: Light Saber Introducer Needle, Minrad, Inc. (2001) Summary page 1.

## Indications for use
The Sterile Stainless Steel Introducer Needle/Cannula with Guide Base is indicated for use to provide temporary percutaneous placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, during minimally invasive laparoscopic procedures.

Source page: https://510kreport.com/device/K103200
Methodology: https://510kreport.com/methodology