Compound W Freeze Off Wart Removal System
FDA 510(k) K060859 · OraSure Technologies, Inc.
510(k) numberK060859
Submission
- Device name
- Compound W Freeze Off Wart Removal System
- Applicant
- OraSure Technologies, Inc.
Bethlehem, PA, US - Received
- March 28, 2006
- Decision date
- July 18, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Compound W Freeze Off Wart Removal System cleared by the FDA?
Compound W Freeze Off Wart Removal System (K060859) received a 510(k) decision of Substantially Equivalent on July 18, 2006, 112 days after the submission was received.
What is the product code of K060859?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.