Mirus Ligating Clip, Mirus Ligating Clip Applier— 510(k) K200166

Substantially Equivalent

M/s. Meril Endo Surgery Private Limited.

FDA 510(k) clearance K200166 for Mirus Ligating Clip, Mirus Ligating Clip Applier, Substantially Equivalent on 2020-11-23. Applicant: M/s. Meril Endo Surgery Private Limited..

Clearance details

Applicant: M/s. Meril Endo Surgery Private Limited.
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2020-01-22
Decision date: 2020-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chala, Vapi, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.