# K091315: Covidien Extended Tip Applicator

- Pathway: 510(k) (Special)
- Applicant: Confluent Surgical,Inc
- Decided: Jun 5, 2009 after 32 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042588 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072790: Confluent Surgical Extended Tip Applicator, Model 70-2008-008, Confluent Surgical,Inc (2008) Summary page 1.

## Recalls of this device
- May 22, 2025 · Class I · Z-1958-2025: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- May 22, 2025 · Class I · Z-1959-2025: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- May 22, 2025 · Class I · Z-1960-2025: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

## Indications for use
The Extended Tip Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.

Source page: https://510kreport.com/device/K091315
Methodology: https://510kreport.com/methodology