# K961560: Eclipse 2000

- Pathway: 510(k) (Traditional)
- Applicant: Cardiogenes
- Decided: Jan 27, 1997 after 291 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- 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. The FDA summary names no predicate by number.

## Indications for use
The Eclipse 2000™ is intended for use in general surgery, including thoracic and abdominal surgeries. This includes the incision, excision, vaporization or coagulation of soft tissue and firm cartilage: o cholecystectomy e lysis of adhesions e hemiorrhaphy o sessile polyps of the intestine and colon e hemorrhoidectomy e condyloma e appendectomy

Source page: https://510kreport.com/device/K961560
Methodology: https://510kreport.com/methodology