MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM— 510(k) K070352

Substantially Equivalent

Mini Lap Technologies, Inc.

FDA 510(k) clearance K070352 for MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM, Substantially Equivalent on 2007-04-05. Applicant: Mini Lap Technologies, Inc..

Clearance details

Applicant: Mini Lap Technologies, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2007-02-06
Decision date: 2007-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.