# K962584: Ultracision 5MM Hard Sheath Laparosonic Blade

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Nov 4, 1996 after 126 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
No predicates in its family tree.
50 later devices descend from it; 1 cites it directly.
0 of 51 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 no predicate by number.

## Most influential descendants
- K993868: The Soundvaser Dissection System (1999), 49 descendants of its own
- K022051: Soundvaser System (2002), 48 descendants of its own
- K042261: Macropore Puricel Lipoplasty System (2004), 36 descendants of its own
- K072587: Cytori Aft System (2007), 34 descendants of its own
- K092482: Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 (2009), 17 descendants of its own

## Indications for use
The UltraCision Smm Hard Sheath LaparoSonic® Blade is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.

Source page: https://510kreport.com/device/K962584
Methodology: https://510kreport.com/methodology