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FDA 510(k)

MOLLI 2

K-Number: K231579 · 2023-10-26

ApplicantMolli Surgical, Inc.
Decision Date2023-10-26
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MOLLI 2 is the device name listed in this FDA 510(k) record. The listed applicant is Molli Surgical, Inc.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K231579. 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?

MOLLI 2 is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Molli Surgical, Inc.. The 510(k) number is K231579.

When did MOLLI 2 receive FDA 510(k) clearance?

MOLLI 2 received FDA 510(k) clearance on 2023-10-26, under 510(k) number K231579.

Who is the listed applicant for MOLLI 2?

The FDA 510(k) record lists Molli Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOLLI 2?

The FDA product code for MOLLI 2 is NEU.

Other records listing Molli Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234149MOLLI 2 SystemK240042MOLLI 2 SystemK223107MOLLI 2K210600MOLLI

Related Devices (Code: NEU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

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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