# K012669: Reprocessed Electrosurgical Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instruments Service and Savings, Inc.
- Decided: Jun 27, 2002 after 318 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Same product as provided by the original manufacturer: named in the summary without a submission number

## Most influential descendants
- K100543: Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01 (2010), 0 descendants of its own

## Recalls of this device
- Mar 5, 2025 · Class II · Z-1547-2025: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- Mar 5, 2025 · Class II · Z-1546-2025: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- Mar 5, 2025 · Class II · Z-1549-2025: Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- May 3, 2013 · Class II · Z-1628-2013: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
- May 3, 2013 · Class II · Z-1644-2013: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

## Indications for use
Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.

Source page: https://510kreport.com/device/K012669
Methodology: https://510kreport.com/methodology