# K193563: Medline ReNewal Reprocessed Harmonic ACE+7 Shears

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
- Decided: Aug 19, 2020 after 240 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: 3 generations back to K072177 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132612: Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 CM Length with Advance, Ethicon Endo-Surgery, LLC (2013) Summary page 6.

## Recalls of this device
- May 7, 2024 · Class II · Z-3095-2024: Potential for an incomplete seal on the packaging tray.
- Aug 3, 2023 · Class II · Z-0120-2024: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

## Indications for use
The Medline ReNewal Harmonic ACE+7 Shears are 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, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

Source page: https://510kreport.com/device/K193563
Methodology: https://510kreport.com/methodology