# K160333: Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Jul 20, 2016 after 163 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K932293 (1994). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142929: Ligasure Blunt Tip Sealer/Divider, Covidien (2015) Summary page 6.

## Recalls of this device
- Oct 1, 2025 · Class II · Z-0471-2026: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
- Oct 1, 2025 · Class II · Z-0472-2026: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
- Oct 1, 2025 · Class II · Z-0473-2026: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
- Oct 1, 2025 · Class II · Z-0474-2026: Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
- May 7, 2024 · Class II · Z-3092-2024: Potential for an incomplete seal on the packaging tray.
- Aug 3, 2023 · Class II · Z-0117-2024: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

## Indications for use
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Source page: https://510kreport.com/device/K160333
Methodology: https://510kreport.com/methodology