# K031846: Cardiovations Optical Bipolar Device

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Jul 21, 2003 after 35 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 1 cites it directly.
2 of 47 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) Clearglide Precision Bipolar Device: named in the summary without a submission number

## Most influential descendants
- K060723: 40 L High Flow Insufflator F113 (2006), 45 descendants of its own
- K063367: 45L Core Insufflator, Model F114 (2007), 44 descendants of its own
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- K110294: High Flow Insufflation Unit Uhi-4 (2011), 32 descendants of its own
- K122180: High Flow Insufflantion Unit (2012), 31 descendants of its own

## Indications for use
The CardioVations Optical Bipolar Device is indicated fat endoscopic and open dissection, bipolar coagulation, and transection of vessels.

Source page: https://510kreport.com/device/K031846
Methodology: https://510kreport.com/methodology