# K972612: Dissectron Portable Unit

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Oct 8, 1997 after 86 days
- Product code: LBK (Neurosurgical Ultrasonic Instruments)
- Device class: U
- 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 K855138 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864983: Cusa System 200 Macro-Dissector, Cooper Lasersonics, Inc. (1987). Our OCR of the scanned summary read K864943, FDA’s number for Numed Balloon Wedge Pressure Catheter (NuMED, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cooper Cavitron CUSA 200M”.
- K883091: Sharplan 4300 & 4310 Ultrasonic Surgical Apirators, Sharplan Lasers, Inc. (1988) Summary page 1.
- K855138: Bovie Ultrasonic Surgical System, Clinical Technology Corp. (1986) Summary page 1.

## Indications for use
Fragmentation, emulsification and aspiration of soft tissue in the neurosurgery field.

Source page: https://510kreport.com/device/K972612
Methodology: https://510kreport.com/methodology