# K994280: Ultracision Harmonic Scalpel Sharp Curved Blade/Fast Blade, Model HF105

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Mar 17, 2000 after 88 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) UltraCision Harmonic Scalpel Curved Blades: named in the summary without a submission number
- (no number) UltraCision Harmonic Scalpel Sharp Hook Blades: named in the summary without a submission number
- (no number) UltraCision Harmonic Scalpel Dissecting Hook Blades: named in the summary without a submission number

## Indications for use
The UltraCision 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.

Source page: https://510kreport.com/device/K994280
Methodology: https://510kreport.com/methodology