# K050343: Reprocessed Harmonic Scalpels

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Apr 12, 2005 after 60 days
- Product code: NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930352 (1993). 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)
- K941897: Ultracison Harmonic Scalpel HS2 Blade, Ultracision, Inc. (1994) Summary page 4.
- K930352: Harmonic Scalpel Reusable Laporascopic Blade Syst., Ultracision, Inc. (1993) Summary page 4.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0549-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th
- Aug 8, 2008 · Not classified · Z-0559-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
The reprocessed harmonic scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.

Source page: https://510kreport.com/device/K050343
Methodology: https://510kreport.com/methodology