# K910253: Leep Redikit

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Apr 18, 1991 after 86 days
- Product code: HEE (Set, Anesthesia, Paracervical)
- Device class: 2
- Regulation: 21 CFR 884.5100
- Recalls of this device: 2 (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
- Sep 1, 2015 · Class III · Z-0105-2016: Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
- Feb 26, 2013 · Class II · Z-1053-2013: LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which 

Source page: https://510kreport.com/device/K910253
Methodology: https://510kreport.com/methodology