510(k) Report

510(k) · Cleared

Cleared

Cryogen Cryosurgical System

K972662510(k) TraditionalCleared Oct 1, 199790-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

Cryogen, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Oct 1, 1997 as substantially equivalent to K811390 (Frigitronics of Connecticut, Inc., 1981) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1981. 1 of the 398 devices in its family, counting itself, has a Class I recall. 393 later devices descend from it.

Decided
Oct 1, 1997
Review
90 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K811390 (1981). 4 ancestors in all. 393 later devices descend from it, 1 citing it directly. 1 of the 398 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor1998: 1 descendant cleared2001: 1 descendant cleared2002: 2 descendants cleared2004: 6 descendants cleared2008: 15 descendants cleared2006: 14 descendants cleared2007: 6 descendants cleared2011: 9 descendants cleared2003: 1 descendant cleared2005: 6 descendants cleared2009: 8 descendants cleared2014: 17 descendants cleared2010: 4 descendants cleared2018: 25 descendants cleared2025: 35 descendants cleared2024: 35 descendants cleared2017: 18 descendants cleared2022: 22 descendants cleared2013: 9 descendants cleared2012: 13 descendants cleared2019: 20 descendants cleared2016: 14 descendants cleared2020: 27 descendants cleared2021: 22 descendants cleared2015: 7 descendants cleared2023: 27 descendants cleared, 1 with a Class I recall12026: 29 descendants clearedK811390 · CCS100 Cryosurgical System · Frigitronics of Connecticut, Inc. · 198119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 12 descendants4 generations forward: 24 descendants5 generations forward: 63 descendants6 generations forward: 60 descendants, 1 with a Class I recall17 generations forward: 54 descendants8 generations forward: 45 descendants9 generations forward: 48 descendants10 generations forward: 30 descendants11 generations forward: 24 descendants12 generations forward: 19 descendants13 generations forward: 9 descendants14 generations forward: 1 descendant K811390 · CCS100 Cryosurgical System · Frigitronics of Connecticut, Inc. · 19810+5+10
  1. Root · 1 generation backK811390 CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc. · 1981
  2. This deviceK972662 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
  3. Descendant · cites it directly · 392 of its ownK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  4. Descendant · 2 generations on · 340 of its ownK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
  5. Descendant · 2 generations on · 268 of its ownK041340 Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
  6. Descendant · 3 generations on · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. Descendant · 4 generations on · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled

Showing 5 of 393 descendants. See all descendants

Descendants cleared per year

1998: 12001: 12002: 22003: 12004: 62005: 62006: 142007: 62008: 152009: 82010: 42011: 92012: 132013: 92014: 172015: 72016: 142017: 182018: 252019: 202020: 272021: 222022: 222023: 272024: 352025: 352026: 29
1998high 35 (2024) · low 0 (1999)2026

Class I recalls in this family

  • K223095 Senhance Surgical System6 generations on · 2023

Most influential descendants

Showing 5 of 393 · See all
  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998 · cites it directly392descendants
  • K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002 · 2 generations on340descendants
  • K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004 · 2 generations on268descendants
  • K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · 3 generations on251descendants
  • K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · 4 generations on231descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K811390CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc.1981—
0 (this device)K972662Cryogen Cryosurgical SystemCryogen, Inc.1997—
+1K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc.1998—
+2K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002—
+2K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004—
+3K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
+4K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199510
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200220
200310
200460
200560
2006140
200760
2008150
200980
201040
201190
2012130
201390
2014170
201570
2016140
2017180
2018250
2019200
2020270
2021220
2022220
2023271
2024350
2025350
2026290
FIG. 1 — Lineage of K972662, 1981–2026Source: 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.

1 device in this family has a Class I recall. 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? (5)

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
*K811390CCS100 Cryosurgical System
Summary page 1
…n Cryosurgical Unit and Accessories (21 name: CFR 878.4350) Predicate devices Device Premarket Notification Frigitronics CE-4 & CE-4G Pre- Amendment Frigitronics CCS 100 K811390 CMS AccuProbe K904421 CMS AccuProbe 550/530 K953637 CryoGen Cryosurgical System 1 K964971 Device description & Principle of Oper…
Frigitronics of Connecticut, Inc.1981—
*K904421CMS Oncoprobe (TM)
Summary page 1
…d Accessories (21 name: CFR 878.4350) Predicate devices Device Premarket Notification Frigitronics CE-4 & CE-4G Pre- Amendment Frigitronics CCS 100 K811390 CMS AccuProbe K904421 CMS AccuProbe 550/530 K953637 CryoGen Cryosurgical System 1 K964971 Device description & Principle of Operation The CryoGen Cry…
Cryomedical Sciences, Inc.1991—
*K953637CMS Accuprobe 550/530
Summary page 1
…8.4350) Predicate devices Device Premarket Notification Frigitronics CE-4 & CE-4G Pre- Amendment Frigitronics CCS 100 K811390 CMS AccuProbe K904421 CMS AccuProbe 550/530 K953637 CryoGen Cryosurgical System 1 K964971 Device description & Principle of Operation The CryoGen Cryosurgery System consists of th…
Cryomedical Sciences, Inc.1995—
*K964971Cryogen Cryosurgical System
Summary page 1
…rket Notification Frigitronics CE-4 & CE-4G Pre- Amendment Frigitronics CCS 100 K811390 CMS AccuProbe K904421 CMS AccuProbe 550/530 K953637 CryoGen Cryosurgical System 1 K964971 Device description & Principle of Operation The CryoGen Cryosurgery System consists of three components: the disposable Control…
Cryogen, Inc.1997—
*—Frigitronics CE-4 & CE-4G
Named without a submission number
—

Also cleared against K811390: 5 other devices →

What descends from it? (393)

See all 393

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc.1998392

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K974320 (Cryogen, Inc., 1998) has gone furthest, with 392 descendants of its own.
  • 5 other devices also cite its predicate K811390.

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 CryoGen Cryosurgical System is indicated for the ablation of tissue by the application of extreme cold in the areas of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K811390

5 other devices cite the same predicate.

  • K111042Atricure Cryo ModuleAtriCure, Inc. · 2011
  • K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 20091 recall
  • K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
  • K040809Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998

More from Cryogen, Inc.

4 FDA decisions under this applicant name. See the company

  • K003050Cryosurgical Unit and AccessoriesCryogen, Inc. · 2000
  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  • K964971Cryogen Cryosurgical SystemCryogen, Inc. · 1997

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/K972662 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972662: Cryogen Cryosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972662

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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