# K905747: Leep System 6000 Electrosurgical Unit and Accessor

- Pathway: 510(k) (Traditional)
- Applicant: Coopervision Surgical
- Decided: Sep 17, 1991 after 267 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Oct 27, 2014 · Class II · Z-0484-2015: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode

Source page: https://510kreport.com/device/K905747
Methodology: https://510kreport.com/methodology