510(k) · Cleared
ClearedCryoshape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etgar Group H.M.Y.A., Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on May 22, 2006 after a 48-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- May 22, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK060928 CryoshapeEtgar Group H.M.Y.A., Ltd. · 2006
- Descendant · cites it directly · 11 of its ownK083493 Myoscience Cryo-TouchMyoscience, Inc. · 2009
- Descendant · 2 generations on · 10 of its ownK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- Descendant · 3 generations on · 9 of its ownK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- Descendant · 2 generations on · 8 of its ownK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK123516 Cryo-Touch IVMyoscience, Inc. · 2013 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K083493Myoscience Cryo-TouchMyoscience, Inc. · 2009 · cites it directly11descendants
- K100447Myoscience Cryo-TouchMyoscience, Inc. · 2010 · 2 generations on10descendants
- K102021Cryo-Touch IIMyoscience, Inc. · 2010 · 3 generations on9descendants
- K120415Cryo-Touch IiiMyoscience, Inc. · 2012 · 2 generations on8descendants
- K123516Cryo-Touch IVMyoscience, Inc. · 2013 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060928 | Cryoshape | Etgar Group H.M.Y.A., Ltd. | 2006 | — |
| +1 | K083493 | Myoscience Cryo-Touch | Myoscience, Inc. | 2009 | — |
| +2 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| +3 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| +2 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| +3 | K123516 | Cryo-Touch IV | Myoscience, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | Cryoprobe Named without a submission number |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083493 | Myoscience Cryo-Touch | 2009 | 11 |
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?
- Of its descendants, K083493 (Myoscience, Inc., 2009) has gone furthest, with 11 descendants of its own.
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 CryoShape is intended to destroy tissue during surgical procedures by applying extreme cold.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060928: Cryoshape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060928
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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