# K990362: Instrument, Ultrasonic, Scalpel

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Sep 17, 1999 after 224 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K881763 (1988). 7 ancestors in all.
33 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983316: Ultracision 5MM Instruments, Ethicon Endo-Surgery, Inc. (1998) Summary page 1.
- K941897: Ultracison Harmonic Scalpel HS2 Blade, Ultracision, Inc. (1994) Summary page 1.
- K924281: Harmonic Scalpel Laparosonic Blade Accessory, Ultracision, Inc. (1993) Summary page 1.
- K955109: VL2600 Handswitching Pencil with Holster, Valleylab, Inc. (1995) Summary page 1.
- K962044: Valleylab Coated Electrodes, Valleylab, Inc. (1996) Summary page 1.
- K964602: Davis Bayonet Electrodes, Valleylab, Inc. (1997) Summary page 1.
- K881763: Colorado Needle Electrode, Colorado Biomedical, Inc. (1988) Summary page 1.

## Cited in the summary but kept off the family tree
- K9715632: Arthrocare Electrosurgery System. Number could not be read Summary page 1.

## Most influential descendants
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- K031710: Olympus Ultrasonic Surgical System (2003), 18 descendants of its own
- K050885: Olympus Ultrasonic Surgical System Sonosurg (2005), 15 descendants of its own
- K111202: Surgical Tissue Management System (2012), 11 descendants of its own
- K132703: Thunderbeat (2014), 9 descendants of its own

## Indications for use
The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic, ENT (Ears, Nose, Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Source page: https://510kreport.com/device/K990362
Methodology: https://510kreport.com/methodology