# K964336: CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680

- Pathway: 510(k) (Traditional)
- Applicant: Cryomedical Sciences, Inc.
- Decided: Mar 20, 1997 after 140 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: 1 generation back to K953637 (1995). 1 ancestor in all.
29 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953637: CMS Accuprobe 550/530, Cryomedical Sciences, Inc. (1995) Summary page 2.

## Most influential descendants
- K072883: Ice-Sense (2007), 26 descendants of its own
- K102360: Icesence 3 (2010), 25 descendants of its own
- K133258: Trufreeze System (2014), 20 descendants of its own
- K143625: truFreeze System (2015), 19 descendants of its own
- K150920: truFreeze System (2015), 11 descendants of its own

## Indications for use
The device is used to destroy unwanted tissue by application of extreme cold to the selected site. LN, is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound or another imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be monitored in real-time through the use of imaging modes such as ultrasound. Once the freezing is completed (approximately 20 minutes) the probe will be heated using warm nitrogen gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue. The cryosurgical procedure is available when surgical resection is not possible and may also provide an alternative to typical resection in certain cases.

Source page: https://510kreport.com/device/K964336
Methodology: https://510kreport.com/methodology