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FDA 510(k)

MOLLI 2 System

K-Number: K234149 · 2024-09-26

ApplicantMolli Surgical, Inc.
Decision Date2024-09-26
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MOLLI 2 System is a medical device manufactured by Molli Surgical, Inc.. It received FDA 510(k) clearance on 2024-09-26 under approval number K234149. 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 2024-09-26. It is manufactured by Molli Surgical, Inc.. The 510(k) number is K234149.

When was MOLLI 2 System approved by the FDA?

MOLLI 2 System received FDA 510(k) clearance on 2024-09-26, under approval number K234149.

What company makes MOLLI 2 System?

MOLLI 2 System is manufactured by Molli Surgical, Inc..

What is the FDA product code for MOLLI 2 System?

The FDA product code for MOLLI 2 System is NEU.

Other Devices by Molli Surgical, Inc.

K210600MOLLI K231579MOLLI 2 K223107MOLLI 2 K240042MOLLI 2 System

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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.

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