# K934320: Mentor Wet-Field Hemostatic Eraser Bipolar Instrument, 20 Gauge with Extrusion Aspiration

- Pathway: 510(k) (Traditional)
- Applicant: Mentor O & O, Inc.
- Decided: Feb 16, 1994 after 166 days
- Product code: HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 11, 2014 · Class II · Z-0527-2015: The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

Source page: https://510kreport.com/device/K934320
Methodology: https://510kreport.com/methodology