510(k) Report

510(k) · Cleared

Cleared

Surgical System with Cryoguide

K002615510(k) TraditionalCleared Nov 13, 200083-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

Endocare, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Nov 13, 2000 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided
Nov 13, 2000
Review
83 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
0

14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2008: 1 descendant cleared2005: 1 descendant cleared2016: 2 descendants cleared2006: 1 descendant cleared2010: 1 descendant cleared2015: 2 descendants cleared2020: 1 descendant cleared2023: 2 descendants cleared2025: 2 descendants cleared200020052010201520202025
  1. This deviceK002615 Surgical System with CryoguideEndocare, Inc. · 2000
  2. Descendant · cites it directly · 13 of its ownK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
  3. Descendant · 2 generations on · 12 of its ownK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
  4. Descendant · 3 generations on · 9 of its ownK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
  5. Descendant · 4 generations on · 8 of its ownK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
  6. Descendant · 5 generations on · 7 of its ownK141110 Cryocare CS Surgical SystemHealthtronics · 2015

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 12008: 12010: 12015: 22016: 22020: 12023: 22025: 2
2003high 2 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 14 · See all
  • K032333Cryocare CS Surgical SystemEndocare, Inc. · 2003 · cites it directly13descendants
  • K050347Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005 · 2 generations on12descendants
  • K060279Cryocare CS Surgical SystemEndocare, Inc. · 2006 · 3 generations on9descendants
  • K101333Cryocare CS Surgical SystemEndocare, Inc. · 2010 · 4 generations on8descendants
  • K141110Cryocare CS Surgical SystemHealthtronics · 2015 · 5 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002615Surgical System with CryoguideEndocare, Inc.2000—
+1K032333Cryocare CS Surgical SystemEndocare, Inc.2003—
+2K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.2005—
+3K060279Cryocare CS Surgical SystemEndocare, Inc.20063
+4K101333Cryocare CS Surgical SystemEndocare, Inc.20102
+5K141110Cryocare CS Surgical SystemHealthtronics2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
200810
201010
201520
201620
202010
202320
202520
FIG. 1 — Lineage of K002615, 2000–2025Source: 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), 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.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K032333Cryocare CS Surgical SystemEndocare, Inc.200313
K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081

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, K032333 (Endocare, Inc., 2003) has gone furthest, with 13 descendants of its own.

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—

More from Endocare, Inc.

22 FDA decisions under this applicant name. See the company

  • K101333Cryocare CS Surgical SystemEndocare, Inc. · 20102 recalls
  • K062175Cryocare CN2 SystemEndocare, Inc. · 2006
  • K060279Cryocare CS Surgical SystemEndocare, Inc. · 20063 recalls
  • K050347Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
  • K032333Cryocare CS Surgical SystemEndocare, Inc. · 2003

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/K002615 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002615: Surgical System with Cryoguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002615

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026