# K060245: Harmonic Scalpel Blades and Shears

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Apr 7, 2006 after 66 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.
52 later devices descend from it; 10 cite it directly.
0 of 53 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) Harmonic Scalpel Blades and Shears: named in the summary without a submission number

## Most influential descendants
- K120729: Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology Harmonic Ace 5MM Diameter Shears 23 (2012), 22 descendants of its own
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- K132612: Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 CM Length with Advance (2013), 16 descendants of its own
- K133314: Harmonic Focus Shears + Adaptive Tissue Technology (2013), 9 descendants of its own
- K160752: HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length (2016), 6 descendants of its own

## Indications for use
The Harmonic Shears 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, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Harmonic Scalpel 5mm Instruments with Protective Sleeve 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 in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space), ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA). The Harmonic Scalpel 10cm Sharp Curved Blade Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery. The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA). The Harmonic Scalpel 5 mm 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, exposure to orthopedic structures (such as spine and joint space), plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA). The Harmonic Scalpel 10 mm LaparoSonic 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 exposure to orthopedic structures (such as spine and joint space).

Source page: https://510kreport.com/device/K060245
Methodology: https://510kreport.com/methodology