# K012685: Reprocessed Endoscopic Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Feb 14, 2002 after 184 days
- Product code: NLW (Electrode, Electrosurgical, Active, Urological, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961702 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961702: Ksea Vaporization Electrodes, Karl Storz Endoskop GmbH (1996) Summary page 6.

## Cited in the summary but kept off the family tree
- K890328: Adult Resectoscope, Circon Video (1990). Our OCR of the scanned summary read K890328, FDA’s number for Adult Resectoscope (Circon Video). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vaportrode Vaporization Electrodes”. Kept off the family tree. Summary page 6.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0573-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.

Source page: https://510kreport.com/device/K012685
Methodology: https://510kreport.com/methodology