# K072203: Harmonic 10CM Combination Hook Blade

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Sep 25, 2007 after 48 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 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 Dissecting Hook Blade: named in the summary without a submission number
- (no number) HARMONIC Sharp Curved Blade: named in the summary without a submission number

## Most influential descendants
- K141122: Harmonic Scallop Blade, Generator G11 (2014), 9 descendants of its own
- K160554: Enseal X1 Large Jaw Tissue Sealer (2016), 6 descendants of its own
- K200841: Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 (2020), 4 descendants of its own
- K233471: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) (2024), 1 descendant of its own
- K212614: Ultrasonic Scalpel System (2022), 1 descendant of its own

## Indications for use
The HarmonicTM instrument 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), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Source page: https://510kreport.com/device/K072203
Methodology: https://510kreport.com/methodology