meddevicedb.com FDA Device Reference

Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection

K170449 Class II Traditional
Decision Date
2017-03-31
Sponsor / Applicant
Millennium Medical Technologies, Inc.

Technical Specification

510(k) Submission ID K170449
Product Code MUU
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.5040
Decision Date 2017-03-31
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection received FDA 510(k) clearance under submission number K170449, sponsored by Millennium Medical Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2017-03-31.

Classification & Regulation

This clearance is catalogued under FDA product code MUU and 21 CFR 878.5040, within the General, Plastic Surgery review panel as a Class II device.