meddevicedb.com FDA Device Reference

Hominis Surgical System

DEN190022 Class II Direct
Decision Date
2021-02-26
Sponsor / Applicant
Momentis Surgical , Ltd.

Technical Specification

510(k) Submission ID DEN190022
Product Code QNM
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4961
Decision Date 2021-02-26
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Hominis Surgical System received FDA 510(k) clearance under submission number DEN190022, sponsored by Momentis Surgical , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-02-26.

Classification & Regulation

This clearance is catalogued under FDA product code QNM and 21 CFR 878.4961, within the General, Plastic Surgery review panel as a Class II device.