Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K-Number: K252889 · 2025-11-25
ApplicantOlympus Medical Systems Corporation
Decision Date2025-11-25
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-11-25 under approval number K252889. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K252889.
When was Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) approved by the FDA?
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) received FDA 510(k) clearance on 2025-11-25, under approval number K252889.
What company makes Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is manufactured by Olympus Medical Systems Corporation.
What is the FDA product code for Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)?
The FDA product code for Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) is KNS.
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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.