510(k) · Cleared
ClearedAccuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryomedical Sciences, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 21, 1997 after an 88-day review. The FDA summary names its predicate without a number. 122 later devices descend from it.
- Decided
- Nov 21, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
122 later devices descend from it, 6 citing it directly.
- This deviceK973190 Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 SeriesCryomedical Sciences, Inc. · 1997
- Descendant · cites it directly · 93 of its ownK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- Descendant · 2 generations on · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- Descendant · 3 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- Descendant · cites it directly · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- Descendant · 4 generations on · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998 · cites it directly93descendants
- K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · 2 generations on92descendants
- K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 3 generations on90descendants
- K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · cites it directly42descendants
- K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · 4 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973190 | Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series | Cryomedical Sciences, Inc. | 1997 | — |
| +1 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| +2 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| +3 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| +1 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| +4 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 10 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 8 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (11)
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 |
|---|---|---|---|
| * | — | Frigitronics Model Zacarian C-21 Named without a submission number | |
| * | — | Frigitronics Model Cryo-Surg Named without a submission number | |
| * | — | Frigitronics Models CM-73 and CT-82 Named without a submission number | |
| * | — | Frigitronics Model CE-4G Named without a submission number | |
| * | — | Frigitronics Models CS-76 and CE-8 Named without a submission number | |
| * | — | ERBE Erbokryo Named without a submission number | |
| * | — | Candela Cryotech Models LCS 2000 and 3000 Named without a submission number | |
| * | — | Brymill Corporation Kryospray Named without a submission number | |
| * | — | Physicians Products, Inc. spray container Named without a submission number | |
| * | — | Spembly Medical 130 Cryounit Named without a submission number | |
| * | — | Cabot Medical's Models MT-700, MT750, FT-350 and MC-8000 Named without a submission number |
What descends from it? (122)
See all 1226 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980110 | Endocre Cryocare Cryosurgical System | 1998 | 93 |
| K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console | 2004 | 42 |
| K072883 | Ice-Sense | 2007 | 26 |
| K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical… | 2006 | 22 |
| K062140 | Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1 | 2006 | 1 |
| K062175 | Cryocare CN2 System | 2006 | 0 |
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, K980110 (Endocare, Inc., 1998) has gone furthest, with 93 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Each proposed intended use description will have the letter (A ) which represents any of the family of AccuProbe® devices, the AccuProbe® 450, AccuProbe® 550/530 and the AccuProbe® 600 Series inclusive. Urology . The (A) system may be used to ablate prostatic tissue. . The (A) system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia.. Oncology . The (A) system may be used for ablation of…
Read the full statement (297 words)
Each proposed intended use description will have the letter (A ) which represents any of the family of AccuProbe® devices, the AccuProbe® 450, AccuProbe® 550/530 and the AccuProbe® 600 Series inclusive.
Urology
. The (A) system may be used to ablate prostatic tissue.
. The (A) system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia..
Oncology
. The (A) system may be used for ablation of cancerous or malignant tissue.
. The (A) system may be used for ablation of benign tumors.
. The (A) system may be used for palliative intervention.
Dermatology
. The (A) system may be used for the ablation or freezing of skin cancers and other cutaneous disorders.
Gynecology
. The (A) system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
General Surgery
. The (A) system may be used for the ablation of leukoplakia of mouth, angiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus areq, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemangiomas, recurrent cancerous lesions.
o The (A) system may be used for the destruction of warts or lesions.
o The (A) system may be used for the palliation of tumors of the oral cavity, rectum, breast, and skin.
Thoracic Surgery
. The (A) system may be used for the ablation of arrhythmic cardiac tissue.
. The (A) system may be used for the ablation of cancerous lesions.
Proctology
o The (A) system may be used for the ablation of benign or malignant growths of the anus and rectum
o The (A) systems may be used for the ablation of hemorrhoids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973190: Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973190
Report an extraction error
Are you the manufacturer?
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