510(k) · Cleared
ClearedAccuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryomedical Sciences, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Sep 8, 1998 as substantially equivalent to K964336 (Cryomedical Sciences, Inc., 1997) after an 89-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Sep 8, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953637 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK953637 CMS Accuprobe 550/530Cryomedical Sciences, Inc. · 1995
- 1 generation backK964336 CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680Cryomedical Sciences, Inc. · 1997
- This deviceK982055 Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860…Cryomedical Sciences, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK062175 Cryocare CN2 SystemEndocare, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062175Cryocare CN2 SystemEndocare, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953637 | CMS Accuprobe 550/530 | Cryomedical Sciences, Inc. | 1995 | — |
| −1 | K964336 | CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680 | Cryomedical Sciences, Inc. | 1997 | — |
| 0 (this device) | K982055 | Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880 | Cryomedical Sciences, Inc. | 1998 | — |
| +1 | K062175 | Cryocare CN2 System | Endocare, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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 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 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964336 | CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680Summary page 3…tate thawing and removal of the cryoprobe from the frozen tissue. Page 2 of 3 COMPARISON OF FEATURES BETWEEN THE AccuProbe® 600 Series [CLEARED 510(k) (K964336)] AND THE AccuProbe® 800 SERIES Liquid Nitrogen Capacity (Dewar size) Model 610 15 liters Model 620 25 liters Model 630 40 lite… | 1997 |
| Kept off the family tree | K972319 | FDA’s K972319 is Aurecast GF Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062175 (Endocare, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K964336.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, 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 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The CMS AccuProbe® 800 Series (all models depicted as A) has the same indications for use as its predicate device, the AccuProbe® 600 Series [510(k) number K?273190 cleared November 21, 1997]. 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…
Read the full statement (281 words)
The CMS AccuProbe® 800 Series (all models depicted as A) has the same indications for use as its predicate device, the AccuProbe® 600 Series [510(k) number K?273190 cleared November 21, 1997].
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 hyperpailsia, basal cell tumors of the eyelid or canthus area, 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.
The (A) system may be used for the destruction of warts or lesions.
The (A) system may be used for the palliation of tumors of the oral cavity, rectum, 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
The (A) system may be used for the ablation of benign or malignant growths of the anus and rectum
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/K982055 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982055: Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982055
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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