Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

510(k) K153745

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK153745	Date2 May 2016Cleared	StatusActive

4 recalls · 4 ongoing · FDA

2 recalls, same reason
- Ongoing Z-0469-2026 FDA Class II initiated 1 Oct 2025
- Ongoing Z-0468-2026 FDA Class II initiated 1 Oct 2025
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.
- Ongoing Z-3094-2024 FDA Class II initiated 7 May 2024
Potential for an incomplete seal on the packaging tray.
- Ongoing Z-0119-2024 FDA Class II initiated 3 Aug 2023
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

1 jurisdiction

United States — FDA 510(k) Active

510(k)