# K083060: Reprocessed Harmonic Scalpel

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jan 9, 2009 after 87 days
- Product code: NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments)
- 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) Ethicon Harmonic WAVE harmonic scalpels: named in the summary without a submission number

## Indications for use
The reprocessed harmonic scalpels are indicated to be used for cutting of soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired. The instrument can be usedas an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space),and other open and endoscopic procedures.

Source page: https://510kreport.com/device/K083060
Methodology: https://510kreport.com/methodology