# K803214: Acmi Bipolar Hemostatic Electrode

- Pathway: 510(k) (Traditional)
- Applicant: American Cystocope Makers, Inc.
- Decided: Jan 15, 1981 after 28 days
- Product code: FEH (Electrode, Flexible Suction Coagulator)
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012018: Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910 (2002), 2 descendants of its own
- K102275: Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240 (2011), 0 descendants of its own
- K101711: Ceruleau Electrosurgical Probe (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K803214
Methodology: https://510kreport.com/methodology