# K871435: Bard Ems System 6000 E.S.U.

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 11, 1987 after 28 days
- Product code: HAM (Apparatus, Electrosurgical)
- 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.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030819: Plasmajet System (2004), 17 descendants of its own
- K090586: Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC) (2009), 16 descendants of its own
- K112233: Bovie J-Plasma Handpiece with Retractable Cutting Blade (2012), 14 descendants of its own
- K151325: Bovie J-Plasma Handpiece (2015), 13 descendants of its own
- K152570: Bovie J-Plasma Precise 360 Handpiece (2015), 12 descendants of its own

## Recalls of this device
- Dec 27, 2012 · Class II · Z-0724-2013: 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

Source page: https://510kreport.com/device/K871435
Methodology: https://510kreport.com/methodology