MOLLI 2 System
K-Number: K253888 · 2025-12-31
ApplicantStryker Endoscopy
Decision Date2025-12-31
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MOLLI 2 System is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2025-12-31 under approval number K253888. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MOLLI 2 System?
MOLLI 2 System is a medical device that received FDA 510(k) clearance on 2025-12-31. It is manufactured by Stryker Endoscopy. The 510(k) number is K253888.
When was MOLLI 2 System approved by the FDA?
MOLLI 2 System received FDA 510(k) clearance on 2025-12-31, under approval number K253888.
What company makes MOLLI 2 System?
MOLLI 2 System is manufactured by Stryker Endoscopy.
What is the FDA product code for MOLLI 2 System?
The FDA product code for MOLLI 2 System is NEU.
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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.