# K012176: Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105, DH145, SH105, SH145

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Oct 1, 2001 after 81 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.
27 later devices descend from it; 2 cite it directly.
0 of 28 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 its predicate without a number.
- (no number) UltraCision® Harmonic Scalpel® Blades with Protective Sleeve: named in the summary without a submission number

## Most influential descendants
- K031305: Olympus Ultrasonic Surgical System (2003), 26 descendants of its own
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- K111202: Surgical Tissue Management System (2012), 11 descendants of its own
- K132703: Thunderbeat (2014), 9 descendants of its own
- K133314: Harmonic Focus Shears + Adaptive Tissue Technology (2013), 9 descendants of its own

## Indications for use
The Harmonic Scalpel 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 scalpel in general, gynecologic, ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of Internal Mammary Artery (IMA).

Source page: https://510kreport.com/device/K012176
Methodology: https://510kreport.com/methodology