# K983316: Ultracision 5MM Instruments

- Pathway: 510(k) (Special)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Oct 21, 1998 after 30 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.
84 later devices descend from it; 2 cite it directly.
0 of 85 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
- K990362: Instrument, Ultrasonic, Scalpel (1999), 33 descendants of its own

## Indications for use
The UltraCision Smm Instruments are 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 in general, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Source page: https://510kreport.com/device/K983316
Methodology: https://510kreport.com/methodology