# K971538: Mentor Gemini Hemostatic Eraser

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Ophthalmics, Inc.
- Decided: Jul 14, 1997 after 77 days
- Product code: HQO (Unit, Cautery, Thermal, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4115
- 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. The FDA summary names its predicate without a number.
- (no number) Mentor® Wet-Field® Hemostatic Eraser® Bipolar Instruments: named in the summary without a submission number

## Most influential descendants
- K024304: Microsurgical Bipolar Handpiece (2003), 2 descendants of its own
- K040584: NMX-1000 (2004), 1 descendant of its own
- K220891: Kahook Dual Blade Glide (KDB Glide) (2024), 0 descendants of its own

## Indications for use
The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.

Source page: https://510kreport.com/device/K971538
Methodology: https://510kreport.com/methodology