# K031675: Smith & Nephew Dyonics Electroblade Resector

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 20, 2003 after 21 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
51 later devices descend from it; 1 cites it directly.
0 of 52 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) 4.5mm Full Radius Bipolar ElectroBladeTM: named in the summary without a submission number
- (no number) 4.5mm Full Radius Elite Bipolar ElectroBladeTM: named in the summary without a submission number

## 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
- Jun 19, 2006 · Not classified · Z-1231-06: Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
- Jun 19, 2006 · Not classified · Z-1230-06: Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
- Jun 19, 2006 · Not classified · Z-1233-06: Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
- Jun 19, 2006 · Not classified · Z-1232-06: Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.

## Indications for use
The Smith & Nephew Dyonics® ElectroBladeTM Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The Smith & Nephew Dyonics® ElectroBladeTM 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/K031675
Methodology: https://510kreport.com/methodology