# K880863: Bipolar Micro Coagulator Models 25-1000 & 25-1200

- Pathway: 510(k) (Traditional)
- Applicant: New England Surgical Instrument Corp.
- Decided: Apr 19, 1988 after 49 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 has not posted a summary or statement for it, 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/K880863
Methodology: https://510kreport.com/methodology