510(k) Report

510(k) · Cleared

Cleared

Cryospray Ablation System, Model CC2-Nam

K072651510(k) AbbreviatedCleared Dec 7, 200779-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

CSA Medical, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Dec 7, 2007 as substantially equivalent to K060555 (Crymed Technologies, Inc., 2006) and 2 other predicates after a 79-day review. Its family tree reaches back 5 generations to 1984.

Decided
Dec 7, 2007
Review
79 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K840536 (1984). 9 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1994: 1 other ancestor1981: 2 other ancestorsK840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 1984K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K040809 · Crymed Cryo-Ablator · Crymed Technologies, Inc. · 2004K060555 · Spraygenix Cryo Ablation System · Crymed Technologies, Inc. · 2006K070893 · Cryospray Ablation System, Model CU 8407020500 · CSA Medical, Inc. · 2007198019851990199520002005
Other ancestors, by generation 2 generations back: 4 other ancestors K070893 · Cryospray Ablation System, Model CU 8407020500 · CSA Medical, Inc. · 2007K060555 · Spraygenix Cryo Ablation System · Crymed Technologies, Inc. · 2006K040809 · Crymed Cryo-Ablator · Crymed Technologies, Inc. · 2004K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 1984−50
  1. Root · 5 generations backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
  2. 4 generations backK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
  3. 3 generations backK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
  4. 2 generations backK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
  5. 1 generation backK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
  6. This deviceK072651 Cryospray Ablation System, Model CC2-NamCSA Medical, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K840536Cryo Surg 5900Frigitronics of Connecticut, Inc.1984—
−4K970995CMS CryoliteCryomedical Sciences, Inc.1997—
−3K040809Crymed Cryo-AblatorCrymed Technologies, Inc.2004—
−2K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc.2006—
−1K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc.2007—
0 (this device)K072651Cryospray Ablation System, Model CC2-NamCSA Medical, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198120
199410
199810
FIG. 1 — Lineage of K072651, 1984–2007Source: 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
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What was it cleared against? (3)

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
*K060555Spraygenix Cryo Ablation System
Summary page 1
…)]. * Establishment Registration Number: 9062377 Predicate Devices Device Premarket Notification SprayGenixTM Cryo Ablation System K060555 CryoSpray Ablation System K070893 CryMed Cryo-Ablator K040809 Company History: CSA Medical, Inc.…
Crymed Technologies, Inc.2006—
*K070893Cryospray Ablation System, Model CU 8407020500
Summary page 1
…9062377 Predicate Devices Device Premarket Notification SprayGenixTM Cryo Ablation System K060555 CryoSpray Ablation System K070893 CryMed Cryo-Ablator K040809 Company History: CSA Medical, Inc., formerly CryMed Technologies, Inc., received…
CSA Medical, Inc.2007—
*K040809Crymed Cryo-Ablator
Summary page 1
…Premarket Notification SprayGenixTM Cryo Ablation System K060555 CryoSpray Ablation System K070893 CryMed Cryo-Ablator K040809 Company History: CSA Medical, Inc., formerly CryMed Technologies, Inc., received market clearance for the SprayGenixTM Cryo…
Crymed Technologies, Inc.2004—

Also cleared against K060555: 3 other devices →

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.

What does this lineage say?

  • The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
  • None of the 9 ancestors has a recall.
  • 3 other devices also cite its predicate K060555.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 CryoSpray AblationTM 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 K060555

3 other devices cite the same predicate.

  • K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc. · 2012
  • K101825Cryoballoon Ablation SystemC2 Therapeutics · 2010
  • K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007

More from CSA Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • K201183Vortex Radial Spray CatheterCSA Medical, Inc. · 2020
  • K171626truFreeze SystemCSA Medical, Inc. · 2017
  • K172041truFreeze SystemCSA Medical, Inc. · 2017
  • K171522truFreeze Rapid AV Spray KitCSA Medical, Inc. · 2017
  • K163244truFreeze SystemCSA Medical, Inc. · 2017

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/K072651 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072651: Cryospray Ablation System, Model CC2-Nam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072651

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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