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SoClean 3+ Bacterial Reduction Device

DEN210037 Class II Direct
Decision Date
2024-08-12
Sponsor / Applicant
Soclean, Inc.

Technical Specification

510(k) Submission ID DEN210037
Product Code QXQ
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.6993
Decision Date 2024-08-12
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

SoClean 3+ Bacterial Reduction Device received FDA 510(k) clearance under submission number DEN210037, sponsored by Soclean, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-08-12.

Classification & Regulation

This clearance is catalogued under FDA product code QXQ and 21 CFR 880.6993, within the General Hospital review panel as a Class II device.