510(k) K023487 ยท GEH Unit, Cryosurgical, Accessories
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Mar 20, 2003 |
| Received | Oct 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2020 | OraSure Technologies, Inc. CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts. Terminated |
GEH | None listed |
| Jul 15, 2020 | OraSure Technologies, Inc. Personelle OTC Skin Tag Remover, Canada
Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags. Terminated |
GEH | None listed |
| Jul 15, 2020 | OraSure Technologies, Inc. Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil
Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags. Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.