Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
K-Number: K242514 · 2025-04-24
ApplicantShenzhen Rogin Medical Co., Ltd.
Decision Date2025-04-24
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is a medical device manufactured by Shenzhen Rogin Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-04-24 under approval number K242514. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is a medical device that received FDA 510(k) clearance on 2025-04-24. It is manufactured by Shenzhen Rogin Medical Co., Ltd.. The 510(k) number is K242514.
When was Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) approved by the FDA?
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) received FDA 510(k) clearance on 2025-04-24, under approval number K242514.
What company makes Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is manufactured by Shenzhen Rogin Medical Co., Ltd..
What is the FDA product code for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?
The FDA product code for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is EKX.
Other Devices by Shenzhen Rogin Medical Co., Ltd.
Related Devices (Code: EKX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.