# K911160: Mentor (R) Wet-Field (R) II AC Coagulator, 22-1305

- Pathway: 510(k) (Traditional)
- Applicant: Mentor O & O, Inc.
- Decided: May 2, 1991 after 48 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K072911: Ion Medical Bipolar Coagulation Pen (2007), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1594-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Apr 26, 2022 · Class II · Z-1281-2022: Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250
- Feb 26, 2018 · Class II · Z-1539-2018: Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
- Feb 26, 2018 · Class II · Z-1801-2018: Products were packaged with incorrect labeling,

Source page: https://510kreport.com/device/K911160
Methodology: https://510kreport.com/methodology