# K864402: Bipolar Electrosurgical Intraocular Probe

- Pathway: 510(k) (Traditional)
- Applicant: New England Surgical Instrument Corp.
- Decided: Jan 20, 1987 after 75 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 7 (7 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.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Nov 14, 2024 · Class I · Z-0656-2025: Potential for the outer stainless-steel tube to break or detach.
- Nov 14, 2024 · Class I · Z-0654-2025: Potential for the outer stainless-steel tube to break or detach.
- Nov 14, 2024 · Class I · Z-0655-2025: Potential for the outer stainless-steel tube to break or detach.
- Nov 14, 2024 · Class I · Z-0657-2025: Potential for the outer stainless-steel tube to break or detach.
- Nov 14, 2024 · Class I · Z-0658-2025: Potential for the outer stainless-steel tube to break or detach.
- Nov 14, 2024 · Class I · Z-0659-2025: Potential for the outer stainless-steel tube to break or detach.
- Nov 14, 2024 · Class I · Z-0660-2025: Potential for the outer stainless-steel tube to break or detach.

Source page: https://510kreport.com/device/K864402
Methodology: https://510kreport.com/methodology