POWERSEAL Curved Jaw Sealer and Divider, Double Action

510(k) K212643

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK212643	Date27 Sep 2021Cleared	StatusActive

7 recalls · 7 ongoing · FDA

- Ongoing Z-3035-2026 FDA Class II initiated 18 Aug 2026
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
3 recalls, same reason
- Ongoing Z-1699-2024 FDA Class II initiated 7 Mar 2024
- Ongoing Z-1700-2024 FDA Class II initiated 7 Mar 2024
- Ongoing Z-1701-2024 FDA Class II initiated 7 Mar 2024
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
3 recalls, same reason
- Ongoing Z-1813-2022 FDA Class II initiated 12 Aug 2022
- Ongoing Z-1814-2022 FDA Class II initiated 12 Aug 2022
- Ongoing Z-1815-2022 FDA Class II initiated 12 Aug 2022
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

1 jurisdiction

United States — FDA 510(k) Active

510(k)