LevaLap Laparoscopic Access Device— 510(k) K212786

Substantially Equivalent

Core Access Surgical Technologies, Inc.

FDA 510(k) clearance K212786 for LevaLap Laparoscopic Access Device, Substantially Equivalent on 2022-02-23. Applicant: Core Access Surgical Technologies, Inc..

Clearance details

Applicant: Core Access Surgical Technologies, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2021-09-01
Decision date: 2022-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.