# K994365: Dyonics Electroblade

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 13, 2000 after 77 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
53 later devices descend from it; 2 cite it directly.
0 of 54 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) Dyonics Arthroscopic Surgery Blades: named in the summary without a submission number
- (no number) Dyonics Electrosurgical Switchpen and Probes: named in the summary without a submission number

## Most influential descendants
- K012314: Dyonics Electroblade Resector (2002), 52 descendants of its own
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own

## Indications for use
The Dyonics ElectroBlade is indicated for use in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues and for coagulation of bleeding.

Source page: https://510kreport.com/device/K994365
Methodology: https://510kreport.com/methodology