OTSCneo System Set (100.03n-14n, 100.27n-31n)
K-Number: K251562 · 2025-12-18
ApplicantOvesco Endoscopy AG
Decision Date2025-12-18
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
OTSCneo System Set (100.03n-14n, 100.27n-31n) is a medical device manufactured by Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2025-12-18 under approval number K251562. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OTSCneo System Set (100.03n-14n, 100.27n-31n)?
OTSCneo System Set (100.03n-14n, 100.27n-31n) is a medical device that received FDA 510(k) clearance on 2025-12-18. It is manufactured by Ovesco Endoscopy AG. The 510(k) number is K251562.
When was OTSCneo System Set (100.03n-14n, 100.27n-31n) approved by the FDA?
OTSCneo System Set (100.03n-14n, 100.27n-31n) received FDA 510(k) clearance on 2025-12-18, under approval number K251562.
What company makes OTSCneo System Set (100.03n-14n, 100.27n-31n)?
OTSCneo System Set (100.03n-14n, 100.27n-31n) is manufactured by Ovesco Endoscopy AG.
What is the FDA product code for OTSCneo System Set (100.03n-14n, 100.27n-31n)?
The FDA product code for OTSCneo System Set (100.03n-14n, 100.27n-31n) is PKL.
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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.