# K072789: Disposable Aem Fixed Tip Electrodes and Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Encision, Inc.
- Decided: Oct 19, 2007 after 18 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Model ES1000 series Monopolar Laparoscopic Electrodes with Electroshield: named in the summary without a submission number
- (no number) Model 30-6000 series Reusable Monopolar Electrodes: named in the summary without a submission number
- (no number) Model 8380 series Bipolar Electrodes: named in the summary without a submission number
- (no number) Models SW11100, SW112100, SW11202, SW11300 (Reusable) and SW11220, SW12202, SW12300 (Disposable) Electrosurgical Pencils: named in the summary without a submission number
- (no number) Model ES4000 AEM Cord (A-EM Monitor accessory): named in the summary without a submission number
- (no number) Model E2508 Disposable Pencil: named in the summary without a submission number

## Most influential descendants
- K093622: Aem Monitoring System, Models EM2, Emr, ES4007, ES4107, ES9005 and ES9015 (2010), 2 descendants of its own
- K122383: EM3 Aem Monitor Aem Connectors (2013), 1 descendant of its own
- K140006: Endoshield Burn Protection System (2014), 0 descendants of its own

## Indications for use
The AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment,

Source page: https://510kreport.com/device/K072789
Methodology: https://510kreport.com/methodology