# K012314: Dyonics Electroblade Resector

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 1, 2002 after 193 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994365 (2000). 1 ancestor in all.
52 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)
- K994365: Dyonics Electroblade, Smith & Nephew, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K102003: Xpress Balloon Device (2010), 36 descendants of its own

## Recalls of this device
- Jul 14, 2012 · Class II · Z-2145-2012: Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
- Jul 14, 2012 · Class II · Z-2144-2012: Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
- Nov 7, 2011 · Not classified · Z-0463-2012: Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.

## Indications for use
The DYONICS Electroblade Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The DYONICS EletroBlade Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer’s lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

Source page: https://510kreport.com/device/K012314
Methodology: https://510kreport.com/methodology