Model 8700 Bipolar Electrosurgical Generator
by Everest Medical Corp. 510(k)
Active
510(k) K870981
Overview
The Model 8700 Bipolar Electrosurgical Generator is an electrosurgical unit designed to provide cutting and coagulation energy using bipolar technology. It delivers controlled electrical current for tissue dissection and hemostasis in surgical procedures.
The device was cleared by the FDA through a traditional 510(k) submission (K870981) as substantially equivalent to a predicate device, classified under product code GEI as a Class II electrosurgical accessory for general and plastic surgery. It is supplied by Everest Medical Corp. and identified by the model number 8700; no sterility or single‑use information is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870981 | Date6 May 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Everest Medical Corp.
Questions
What surgical applications is the Model 8700 designed for?
The Model 8700 is intended for use in general and plastic surgery procedures where precise tissue dissection and reliable hemostasis are required. Its bipolar technology allows surgeons to cut and coagulate simultaneously, reducing the need for separate instruments and improving workflow in these specialties.
How is the Model 8700 supplied and is it sterile?
The generator is supplied by Everest Medical Corp. as a non‑sterile unit; the data does not specify any sterility labeling or single‑use status. Because it is an electrosurgical generator, it is typically used in the operating room with sterile handpieces that are attached separately.
Is the Model 8700 a single‑use device or can it be reused?
The information provided does not indicate a single‑use designation, so the generator itself is a reusable piece of equipment. Clinical practice usually involves reprocessing the unit according to the manufacturer’s maintenance guidelines, while any disposable accessories would be handled separately.
What regulatory pathway was used for the Model 8700 clearance?
The Model 8700 received FDA clearance through a traditional 510(k) submission (K870981), demonstrating substantial equivalence to a predicate electrosurgical accessory. This pathway classifies the device as a Class II product under product code GEI.