510(k) · Cleared
ClearedCMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryomedical Sciences, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jul 17, 1998 after a 147-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 17, 1998
- Review
- 147 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Cryo-lite™ System Named without a submission number | |
| * | — | AccuProbe® 600 Series Named without a submission number | |
| * | — | Cabot Medical's Cryomedics MT700 Named without a submission number | |
| * | — | Erbe Erbokryo CA Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721and 722, depending on the cryogen selected, are intended to be used: Liquid Nitrogen: as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology. gynecology and ENT; to ablate prostatic tissue; for the ablation of prostatic tissue in cases of prostate cancer and benign prostatic hyperplasia…
Read the full statement (272 words)
The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721and 722, depending on the cryogen selected, are intended to be used:
Liquid Nitrogen:
as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology. gynecology and ENT;
to ablate prostatic tissue;
for the ablation of prostatic tissue in cases of prostate cancer and benign prostatic hyperplasia;
for ablation of cancerous or malignant tissue;
for ablation of benign tumors;
for palliative intervention;
for ablation or freezing of skin cancers and other cutaneous disorders;
for the ablation of malignant neoplasia or benign dysplasia of the female genitalia;
for ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid and canthus areaq, vlcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions;
for the destruction of warts or lesions;
for the palliation of tumors of the oral cavity, rectum, and skin;.
for ablation of arrhythmic cardiac tissue;
for the ablation of benign or malignant growths of the anus and rectum;
for the ablation of hemorrhoids;
Nitrous Oxide:
as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, and urology;
Carbon Dioxide:
as a tool in the destruction of unwanted tissue in the fields of germotology, gynecology, and general surgery;
Argon and Krypton:
as a cryosurgical tool in general surgery, dermatology. neurology, thoracic surgery, ENT, gynecology, oncology, proctology. and urology for the ablation of tissue including liver metastases, skin lesions, warts and prostate tissue;
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980670 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980670: CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980670
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026