HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME— 510(k) K023487

Name: FDA 510(k) clearance K023487
Creator: U.S. Food and Drug Administration
Published: 2003-03-20

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K023487 for HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME, Substantially Equivalent on 2003-03-20. Applicant: OraSure Technologies, Inc.. Device class: 2.

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code GEH
Device class: Class 2
Regulation: 21 CFR 878.4350
Advisory panel: General, Plastic Surgery
Date received: 2002-10-17
Decision date: 2003-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K023487

K-number listed on FDA's recall record

Z-3001-2020 — 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.Class III·Terminated·OraSure Technologies, Inc.·20200715
Z-3002-2020 — 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.Class III·Terminated·OraSure Technologies, Inc.·20200715
Z-3003-2020 — 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.Class III·Terminated·OraSure Technologies, Inc.·20200715

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023487.

Data sourced from openFDA. This site is unofficial and independent of the FDA.