510(k) Report

FDA applicant

Cryosurgery, Inc.

Nashville, TN9 decisions1994–20260 recalls

FDA records 9 decisions for Cryosurgery, Inc. (Nashville, TN) from 1994 to 2026: 9 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and MLY (Vapocoolant Device). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 77 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. 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 Cryosurgery, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2023: 12024: 12025: 32026 (partial year): 1
2007high 3 (2025) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cryosurgery, 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, Accessories8decisions
  • MLYVapocoolant Device1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 29 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 77 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 3 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.

  • K982506Verruca-Freeze Cryosurgery Delivery SystemCryosurgery, Inc. · 19993cite it
  • K944221Verruca-Freeze (TM) Cryosurgical Delivery Syst, ModifiedCryosurgery, Inc. · 19942cite it
  • K233347Verruca-Freeze® HCryosurgery, Inc. · 20231cites it
  • K955083Verruca-Freeze Cryosurgical Delivery System (Modification)Cryosurgery, Inc. · 19961cites it
  • K243454Verruca-Freeze HCryosurgery, Inc. · 20241cites it
  • K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 20251cites it

What has FDA decided for it lately?

  • K261684FreezeSpray TACryosurgery, Inc. · 2026
  • K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
  • K252903Verruca-Freeze H PlusCryosurgery, Inc. · 2025
  • K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
  • K243454Verruca-Freeze HCryosurgery, Inc. · 2024
  • K233347Verruca-Freeze® HCryosurgery, Inc. · 2023
  • K982506Verruca-Freeze Cryosurgery Delivery SystemCryosurgery, Inc. · 1999
  • K955083Verruca-Freeze Cryosurgical Delivery System (Modification)Cryosurgery, Inc. · 1996

All 9 as Cryosurgery, Inc. →