510(k) · Cleared
ClearedCMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680
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 Mar 20, 1997 as substantially equivalent to K953637 (Cryomedical Sciences, Inc., 1995) after a 140-day review. Its family tree reaches back 1 generation to 1995. 29 later devices descend from it.
- Decided
- Mar 20, 1997
- Review
- 140 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953637 (1995). 29 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK953637 CMS Accuprobe 550/530Cryomedical Sciences, Inc. · 1995
- This deviceK964336 CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680Cryomedical Sciences, Inc. · 1997
- Descendant · cites it directly · 26 of its ownK072883 Ice-SenseArbel Medical, Ltd. · 2007
- Descendant · 2 generations on · 25 of its ownK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- Descendant · 3 generations on · 20 of its ownK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 19 of its ownK143625 truFreeze SystemCSA Medical, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 11 of its ownK150920 truFreeze SystemCSA Medical, Inc. · 2015
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K072883Ice-SenseArbel Medical, Ltd. · 2007 · cites it directly26descendants
- K102360Icesence 3IceCure Medical, Ltd. · 2010 · 2 generations on25descendants
- K133258Trufreeze SystemCSA Medical, Inc. · 2014 · 3 generations on20descendants
- K143625truFreeze SystemCSA Medical, Inc. · 2015 · 4 generations on19descendants
- K150920truFreeze SystemCSA Medical, Inc. · 2015 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953637 | CMS Accuprobe 550/530 | Cryomedical Sciences, Inc. | 1995 | — |
| 0 (this device) | K964336 | CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680 | Cryomedical Sciences, Inc. | 1997 | — |
| +1 | K072883 | Ice-Sense | Arbel Medical, Ltd. | 2007 | — |
| +2 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| +3 | K133258 | Trufreeze System | CSA Medical, Inc. | 2014 | 1 |
| +4 | K143625 | truFreeze System | CSA Medical, Inc. | 2015 | 1 |
| +5 | K150920 | truFreeze System | CSA Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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? (1)
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 |
|---|---|---|---|
| * | K953637 | CMS Accuprobe 550/530Summary page 2…ed for marketing in November 20, 1995. The intended use and principal of operation are the same. COMPARISON OF FEATURES BETWEEN THE AccuProbe® 550/530 [CLEARED 510(k) (K953637)] AND THE AccuProbe® 600 SERIES Liquid Nitrogen Capacity (Dewar size) 85 liters Model 610 15 liters Model 620 25 liters Model… | 1995 |
What descends from it? (29)
See all 293 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
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 device is used to destroy unwanted tissue by application of extreme cold to the selected site. LN, is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound or another imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be monitored in real-time through the use of imaging modes such as ultrasound. Once the freezing is completed…
Read the full statement (121 words)
The device is used to destroy unwanted tissue by application of extreme cold to the selected site. LN, is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound or another imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be monitored in real-time through the use of imaging modes such as ultrasound. Once the freezing is completed (approximately 20 minutes) the probe will be heated using warm nitrogen gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue. The cryosurgical procedure is available when surgical resection is not possible and may also provide an alternative to typical resection in certain cases.
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/K964336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964336: CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964336
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026