# K982055: Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880

- Pathway: 510(k) (Traditional)
- Applicant: Cryomedical Sciences, Inc.
- Decided: Sep 8, 1998 after 89 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953637 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964336: CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680, Cryomedical Sciences, Inc. (1997) Summary page 3.

## Cited in the summary but kept off the family tree
- K972319: Aurecast GF, Aurex Precious Metal Industries (Pty)Ltd (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K062175: Cryocare CN2 System (2006), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K982055
Methodology: https://510kreport.com/methodology