# K072559: Suction Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Oct 5, 2007 after 24 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K791752 (1979). 1 ancestor in all.
6 later devices descend from it; 1 cites 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 2.

## Cited in the summary but kept off the family tree
- K946327: MegaDyne Suction Coagulator. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K091223: Valleylab Suction Coagulator, Model E3305 (2009), 5 descendants of its own
- 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

## Recalls of this device
- Jun 15, 2023 · Class II · Z-2257-2023: An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plug
- Feb 27, 2014 · Class II · Z-1151-2014: Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number

## Indications for use
The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

Source page: https://510kreport.com/device/K072559
Methodology: https://510kreport.com/methodology