Ultravision2 System Integrated Monopolar L-Hook (H/S)
K-Number: K231298 · 2023-10-31
ApplicantAlesi Surgical, Ltd.
Decision Date2023-10-31
Product CodePQM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Ultravision2 System Integrated Monopolar L-Hook (H/S) is a medical device manufactured by Alesi Surgical, Ltd.. It received FDA 510(k) clearance on 2023-10-31 under approval number K231298. The device is classified under product code PQM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ultravision2 System Integrated Monopolar L-Hook (H/S)?
Ultravision2 System Integrated Monopolar L-Hook (H/S) is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Alesi Surgical, Ltd.. The 510(k) number is K231298.
When was Ultravision2 System Integrated Monopolar L-Hook (H/S) approved by the FDA?
Ultravision2 System Integrated Monopolar L-Hook (H/S) received FDA 510(k) clearance on 2023-10-31, under approval number K231298.
What company makes Ultravision2 System Integrated Monopolar L-Hook (H/S)?
Ultravision2 System Integrated Monopolar L-Hook (H/S) is manufactured by Alesi Surgical, Ltd..
What is the FDA product code for Ultravision2 System Integrated Monopolar L-Hook (H/S)?
The FDA product code for Ultravision2 System Integrated Monopolar L-Hook (H/S) is PQM.
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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.