# K033003: Suction Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Modern Medical Equipment Mfg., Ltd.
- Decided: May 13, 2004 after 231 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052104: Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction (2005), 26 descendants of its own
- K073616: Fas-Clean Electrosurgical Coated Active Blade (2008), 25 descendants of its own
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices (2008), 24 descendants of its own
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device (2010), 8 descendants of its own
- K142410: Elliquence Electrodes (2015), 7 descendants of its own

## Recalls of this device
- Nov 18, 2022 · Class II · Z-0474-2023: Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in proced

## Indications for use
Suction coagulator is used for coagulating tissue and removing fluid and debris from surgical site. Suction and coagulation can be performed independently or simultaneously.

Source page: https://510kreport.com/device/K033003
Methodology: https://510kreport.com/methodology