MINI LAP RETRACTORS— 510(k) K093449

Substantially Equivalent

Mini Lap Technologies, Inc.

FDA 510(k) clearance K093449 for MINI LAP RETRACTORS, Substantially Equivalent on 2010-02-12. Applicant: Mini Lap Technologies, Inc..

Clearance details

Applicant: Mini Lap Technologies, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2009-11-05
Decision date: 2010-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.