Single Use Electrosurgical Knife Series, Model Kd-610l, Kd-611l, Kd-620LR, Kd-630l, Kf-640l

510(k) K092309

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 · Traditional	NumberK092309	Date30 Oct 2009Cleared	StatusActive

9 recalls · 1 ongoing · FDA

- Ongoing Z-1222-2026 FDA Class II initiated 17 Feb 2024
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
8 recalls, same reason
- Terminated Z-0978-2021 FDA Class II initiated 4 Jan 2021
- Terminated Z-0980-2021 FDA Class II initiated 4 Jan 2021
- Terminated Z-0975-2021 FDA Class II initiated 4 Jan 2021
- Terminated Z-0981-2021 FDA Class II initiated 4 Jan 2021
- Terminated Z-0979-2021 FDA Class II initiated 4 Jan 2021
- Terminated Z-0976-2021 FDA Class II initiated 4 Jan 2021
- Terminated Z-0977-2021 FDA Class II initiated 4 Jan 2021
- Terminated Z-0974-2021 FDA Class II initiated 4 Jan 2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

1 jurisdiction

United States — FDA 510(k) Active

510(k)