510(k) K242803

Compound W Skin Tag Remover by Medtech Products, Inc. — Product Code GEH

K242803 is an FDA 510(k) premarket notification submitted by Medtech Products, Inc. for the device "Compound W Skin Tag Remover". The FDA issued a decision of Substantially Equivalent on November 6, 2024. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Medtech Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2024
Date Received
September 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type