# K991855: Conmed Stealth Non-Stick Accessory Electrode, Model 138XXX

- Pathway: 510(k) (Special)
- Applicant: Conmedcorp
- Decided: Jun 15, 1999 after 14 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 14 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081559: Genesis (2008), 0 descendants of its own

## Recalls of this device
- Dec 27, 2012 · Class II · Z-0720-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0722-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0733-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0734-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0721-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0723-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0729-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0730-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0731-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0736-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0737-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0735-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Dec 27, 2012 · Class II · Z-0732-2013: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no insta
- Nov 2, 2007 · Not classified · Z-0452-2008: Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal

## Indications for use
CoNMED Stealth® Non-Stick Accessory Electrode is designed to fit all CoNMeD and most other electrosurgical pencils and chuck handles and intended for use in monopolar electrosurgical procedures for the dissection and coagulation of tissue. The electrode blade is to be a direct alternative to other electrode blades in distribution and will be made available in a variety of tip configurations for differing circumstances encountered during surgical procedures.

Source page: https://510kreport.com/device/K991855
Methodology: https://510kreport.com/methodology