# K080793: Firmgrip

- Pathway: 510(k) (Traditional)
- Applicant: Flexicath, Ltd.
- Decided: Oct 16, 2008 after 210 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930473 (1994). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063363: Firmgrip Peripherally Inserted Catheter Device, Flexicath, Ltd. (2007) Summary page 2.

## Most influential descendants
- K092629: SNM Firmgrip (2009), 1 descendant of its own
- K111939: M/29TM - Pressure Injectable (2012), 0 descendants of its own

## Indications for use
The FirmGrip TM Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

Source page: https://510kreport.com/device/K080793
Methodology: https://510kreport.com/methodology