# K123319: Gyrus Acmi Bicoag Hemostasis Probe

- Pathway: 510(k) (Special)
- Applicant: Olympus Surgical Technologies America
- Decided: Dec 14, 2012 after 49 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K892895 (1989). 4 ancestors in all.
1 later device descends 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)
- K092571: Gyrus Acmi Biocoag Probe, Gyrus Acmi, Inc. (2010) Summary page 1.

## Most influential descendants
- K232633: Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter (2023), 0 descendants of its own

## Recalls of this device
- Aug 19, 2026 · Class II · Z-3245-2026: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
- Aug 19, 2026 · Class II · Z-3247-2026: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
- Aug 19, 2026 · Class II · Z-3244-2026: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
- Aug 19, 2026 · Class II · Z-3246-2026: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
- Jan 5, 2024 · Class II · Z-1481-2024: The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

## Indications for use
The Gyrus ACMI 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/K123319
Methodology: https://510kreport.com/methodology