# K935091: Aspen Surgical Systems Coated Blade Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Feb 28, 1994 after 126 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 2, 2007 · Not classified · Z-0452-2008: Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal

Source page: https://510kreport.com/device/K935091
Methodology: https://510kreport.com/methodology