# K193137: EASYGRIP FLO-41 Precision MIS Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corportation
- Decided: Jan 8, 2020 after 56 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913172 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123847: Malleable Tip Endoscopic Applicator, Micromedics, Inc. (2013) Summary page 5.

## Recalls of this device
- Jun 15, 2021 · Class II · Z-2051-2021: There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date

## Indications for use
The EASYGRIP FLO-41 Precision MIS Delivery System is indicated for delivering compatible hemostatic agents to bleeding sites through a 5 mm or larger trocar.

Source page: https://510kreport.com/device/K193137
Methodology: https://510kreport.com/methodology