# K041328: Smith & Nephew Electroblade Resector/Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 27, 2004 after 69 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
Longest line of descent: 2 generations back to K994365 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012314: Dyonics Electroblade Resector, Smith & Nephew, Inc. (2002) Summary page 3.
- (no number) Erbe Icc 350: named in the summary without a submission number

## Indications for use
The Smith & Nephew ElectroBlade Adaptor, when used in conjunction with The Smith & Nephew ElectroBlade Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft tissue. The Smith & Nephew ElectroBlade 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/K041328
Methodology: https://510kreport.com/methodology