# K091223: Valleylab Suction Coagulator, Model E3305

- Pathway: 510(k) (Traditional)
- Applicant: Covidien LP
- Decided: Sep 11, 2009 after 137 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K791752 (1979). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791752: Lectrovac, Valleylab Models, Valleylab, Inc. (1979) Summary page 1.
- K072559: Suction Coagulator, Megadyne Medical Products, Inc. (2007) Summary page 1.

## Most influential descendants
- K121678: DTAD (2012), 2 descendants of its own
- K123429: Olympus Energy Power System (Eps) (2013), 1 descendant of its own
- K103775: Peak Suction Coagulator (2011), 1 descendant of its own
- K212650: Celeris, Disposable Sinus Debrider (2022), 0 descendants of its own
- K150297: PlasmaBlade UPPP and Suction Coagulator (2015), 0 descendants of its own

## Indications for use
The Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.

Source page: https://510kreport.com/device/K091223
Methodology: https://510kreport.com/methodology