# K092571: Gyrus Acmi Biocoag Probe

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Oct 20, 2010 after 425 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- 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
Longest line of descent: 1 generation back to K892895 (1989). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912129: Dobbhoff (R) Bipolar Hemostatic Probe, Biosearch Medical Products, Inc. (1991) Summary page 1.
- K892895: Model 8800 Bipolar Coagulation Therapeutic System, Everest Medical Corp. (1989) Summary page 1.
- K912601: Biprobe (TM), C.R. Bard, Inc. (1991) Summary page 1.

## Most influential descendants
- K123319: Gyrus Acmi Bicoag Hemostasis Probe (2012), 1 descendant of its own
- K232633: Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter (2023), 0 descendants of its own

## Indications for use
The Gyrus ACMI Inc. BiCoag Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract during endoscopic procedures.

Source page: https://510kreport.com/device/K092571
Methodology: https://510kreport.com/methodology