# K973190: Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series

- Pathway: 510(k) (Traditional)
- Applicant: Cryomedical Sciences, Inc.
- Decided: Nov 21, 1997 after 88 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
122 later devices descend from it; 6 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Frigitronics Model Zacarian C-21: named in the summary without a submission number
- (no number) Frigitronics Model Cryo-Surg: named in the summary without a submission number
- (no number) Frigitronics Models CM-73 and CT-82: named in the summary without a submission number
- (no number) Frigitronics Model CE-4G: named in the summary without a submission number
- (no number) Frigitronics Models CS-76 and CE-8: named in the summary without a submission number
- (no number) ERBE Erbokryo: named in the summary without a submission number
- (no number) Candela Cryotech Models LCS 2000 and 3000: named in the summary without a submission number
- (no number) Brymill Corporation Kryospray: named in the summary without a submission number
- (no number) Physicians Products, Inc. spray container: named in the summary without a submission number
- (no number) Spembly Medical 130 Cryounit: named in the summary without a submission number
- (no number) Cabot Medical's Models MT-700, MT750, FT-350 and MC-8000: named in the summary without a submission number

## Most influential descendants
- K980110: Endocre Cryocare Cryosurgical System (1998), 93 descendants of its own
- K011722: Atricure Bipolar Coagulation System (2001), 92 descendants of its own
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), 90 descendants of its own
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own
- K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System (2003), 34 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K973190
Methodology: https://510kreport.com/methodology