# K212786: LevaLap Laparoscopic Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Core Access Surgical Technologies, Inc.
- Decided: Feb 23, 2022 after 175 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K852726 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073452: Modification to: Aragon Surgical Lapcap, Aragon Surgical, Inc. (2008) Summary page 4.

## Indications for use
The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region of the abdominal wall prior to the establishment of a pneumoperitoneum to aid in the insertion of a Veress needle during gynecologic (pelvic) and general surgical (intra-abdominal) laparoscopic procedures.

Source page: https://510kreport.com/device/K212786
Methodology: https://510kreport.com/methodology