510(k) Report

510(k) · Cleared

Cleared

Spraygenix Cryo Ablation System

K060555510(k) TraditionalCleared Apr 21, 200650-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Crymed Technologies, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Apr 21, 2006 as substantially equivalent to K040809 (Crymed Technologies, Inc., 2004) and 6 other predicates after a 50-day review. Its family tree reaches back 3 generations to 1984. 15 later devices descend from it.

Decided
Apr 21, 2006
Review
50 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K840536 (1984). 7 ancestors in all, the oldest K811390 (1981). 15 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1994: 1 other ancestor1981: 2 other ancestors2012: 1 descendant cleared2010: 1 descendant cleared2007: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2016: 3 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant clearedK840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 1984K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K040809 · Crymed Cryo-Ablator · Crymed Technologies, Inc. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant K040809 · Crymed Cryo-Ablator · Crymed Technologies, Inc. · 2004K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 19840+5
  1. Root · 3 generations backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
  2. 2 generations backK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
  3. 1 generation backK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
  4. This deviceK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
  5. Descendant · cites it directly · 13 of its ownK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
  6. Descendant · cites it directly · 11 of its ownK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
  7. Descendant · 2 generations on · 10 of its ownK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · Recalled
  8. Descendant · 3 generations on · 8 of its ownK151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe…C2 Therapeutics, Inc. · 2015
  9. Descendant · 3 generations on · 6 of its ownK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2007: 22010: 12012: 12013: 12015: 12016: 32017: 12018: 12019: 12020: 12021: 12024: 1
2007high 3 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 15 · See all
  • K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007 · cites it directly13descendants
  • K101825Cryoballoon Ablation SystemC2 Therapeutics · 2010 · cites it directly11descendants
  • K131523Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · 2 generations on10descendants
  • K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2015 · 3 generations on8descendants
  • K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 2016 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K840536Cryo Surg 5900Frigitronics of Connecticut, Inc.1984—
−2K970995CMS CryoliteCryomedical Sciences, Inc.1997—
−1K040809Crymed Cryo-AblatorCrymed Technologies, Inc.2004—
0 (this device)K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc.2006—
+1K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc.2007—
+1K101825Cryoballoon Ablation SystemC2 Therapeutics2010—
+2K131523Cryoballoon Focal Ablation SystemC2 Therapeutics20132
+3K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon…C2 Therapeutics, Inc.2015—
+3K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe…C2 Therapeutics, Inc.20161

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198120
199410
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
201010
201210
201310
201510
201630
201710
201810
201910
202010
202110
202410
FIG. 1 — Lineage of K060555, 1984–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K040809Crymed Cryo-Ablator
Summary page 1
…tablishment Registration Number: 9062377 Predicate Devices Device Premarket Notification CryMed Cryo-Ablator K040809 Wallach Surgical Devices WA1000 K813024 Figitronics Cryo-Plus TM K811390 Figitronics Cryo-Sur…
Crymed Technologies, Inc.2004—
*K813024WA1000
Summary page 1
…cate Devices Device Premarket Notification CryMed Cryo-Ablator K040809 Wallach Surgical Devices WA1000 K813024 Figitronics Cryo-Plus TM K811390 Figitronics Cryo-Surg TMSystem 5900 K840536 Wallach Surgical Dev…
Wallach Surgical Devices, Inc.1981—
*K811390CCS100 Cryosurgical System
Summary page 1
…arket Notification CryMed Cryo-Ablator K040809 Wallach Surgical Devices WA1000 K813024 Figitronics Cryo-Plus TM K811390 Figitronics Cryo-Surg TMSystem 5900 K840536 Wallach Surgical Devices UltraFreeze K935010 Cortex Technology's…
Frigitronics of Connecticut, Inc.1981—
*K840536Cryo Surg 5900
Summary page 1
…K040809 Wallach Surgical Devices WA1000 K813024 Figitronics Cryo-Plus TM K811390 Figitronics Cryo-Surg TMSystem 5900 K840536 Wallach Surgical Devices UltraFreeze K935010 Cortex Technology's Cryopro Maxi and Cryopro Mini…
Frigitronics of Connecticut, Inc.1984—
*K935010Wallach Ultra Freeze
Summary page 1
…K813024 Figitronics Cryo-Plus TM K811390 Figitronics Cryo-Surg TMSystem 5900 K840536 Wallach Surgical Devices UltraFreeze K935010 Cortex Technology's Cryopro Maxi and Cryopro Mini K982280 CMS Cryolite…
Wallach Surgical Devices, Inc.1994—
*K982280Cryopro Maxi and Cryopro Mini
Summary page 1
…yo-Surg TMSystem 5900 K840536 Wallach Surgical Devices UltraFreeze K935010 Cortex Technology's Cryopro Maxi and Cryopro Mini K982280 CMS Cryolite K970995 Device Description The SprayGenix TM Cryo Ablation System is a cryosurgic…
Cortex Technology Aps1998—
*K970995CMS Cryolite
Summary page 1
…al Devices UltraFreeze K935010 Cortex Technology's Cryopro Maxi and Cryopro Mini K982280 CMS Cryolite K970995 Device Description The SprayGenix TM Cryo Ablation System is a cryosurgical device, consisting of an electronic console, cry…
Cryomedical Sciences, Inc.1997—

Also cleared against K040809: 2 other devices →

What descends from it? (15)

See all 15

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc.200713
K101825Cryoballoon Ablation SystemC2 Therapeutics201011
K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc.20120
K072651Cryospray Ablation System, Model CC2-NamCSA Medical, Inc.20070

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?

  • The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K070893 (CSA Medical, Inc., 2007) has gone furthest, with 13 descendants of its own.
  • 2 other devices also cite its predicate K040809.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

What is it indicated for?

The SprayGeniX TM Cryo Ablation System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Indications for use as stated in the FDA summary.

Also cleared against K040809

2 other devices cite the same predicate.

  • K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc. · 2012
  • K072651Cryospray Ablation System, Model CC2-NamCSA Medical, Inc. · 2007

More from Crymed Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K040809Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K060555 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060555: Spraygenix Cryo Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060555

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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