# K211273: Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray

- Pathway: 510(k) (Special)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: May 21, 2021 after 24 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
Longest line of descent: 1 generation back to K002906 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063192: Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test Tip, Ethicon Endo-Surgery, LLC (2007) Summary page 4.
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 4.

## Indications for use
The HARMONIC® Blue Hand Piece, when used in conjunction with the HARMONIC® Instruments, 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. The HARMONIC® Gray Hand Piece, when used in conjunction with the HARMONIC® Instruments, 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.

Source page: https://510kreport.com/device/K211273
Methodology: https://510kreport.com/methodology