510(k) Report

FDA applicant

Cryosurg, Inc.

Nashville, TN1 decision1988–19880 recalls

FDA records 1 decision for Cryosurg, Inc. (Nashville, TN) in 1988: 1 510(k) clearance. All are in product code GEH (Unit, Cryosurgical, Accessories). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Cryosurg, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cryosurg, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cryosurg, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cryosurg, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEHUnit, Cryosurgical, Accessories1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K881349Verruca-Freeze (TM) Cryotherapy Delivery SystemCryosurg, Inc. · 19882cite it

What has FDA decided for it lately?

  • K881349Verruca-Freeze (TM) Cryotherapy Delivery SystemCryosurg, Inc. · 1988

The one decision as Cryosurg, Inc. →