# K993628: Omnisonics Ultrasonic Probes

- Pathway: 510(k) (Traditional)
- Applicant: Omnisonics Medical Technologies
- Decided: Dec 15, 1999 after 49 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- 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: 2 generations back to K884413 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990572: Sonotome, Sonokinetics, Inc. (1999) Summary page 3.
- K853143: Cooper Laser Sonics Cusa Model 200, Cooper Lasersonics, Inc. (1985) Summary page 1.
- K864983: Cusa System 200 Macro-Dissector, Cooper Lasersonics, Inc. (1987) Summary page 1.
- K884412: Cusa System 200C,T & M Ultrasonic Surgical Aspira., Valleylab, Inc. (1988) Summary page 1.
- K884413: Cusa System 200H Ultrasonic Surgical Aspirator, Valleylab, Inc. (1988) Summary page 1.
- K894600: Cusa System 200C,T,M,H Ultrasonic Aspirator, Valleylab, Inc. (1990) Summary page 1.
- K910696: Cusa (R) System 200C/200T/200M/200H Ultra Aspirator, Valleylab, Inc. (1991) Summary page 1.
- K981262: Cusa Excel Ultrasonic Surgical Aspirator System, Valleylab, Inc. (1998) Summary page 1.

## Indications for use
The intended use of the OmniSonics Ultrasonic Probes is the breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic. The OmniSonics Ultrasonic Probes are used in conjunction with the OmniSonics Ultrasonic Surgical System. The OmniSonics Ultrasonic Probes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the probe.

Source page: https://510kreport.com/device/K993628
Methodology: https://510kreport.com/methodology