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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2025-12-31 under 510(k) 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. The listed applicant is Stryker Endoscopy. The 510(k) number is K253888.

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

MOLLI 2 System received FDA 510(k) clearance on 2025-12-31, under 510(k) number K253888.

Who is the listed applicant for MOLLI 2 System?

The FDA 510(k) record lists Stryker Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOLLI 2 System?

The FDA product code for MOLLI 2 System is NEU.

Related Clinical Trials

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.

NCT07631468PROspect Registry :Post Market Clinical Follow-up StudyNOT_YET_RECRUITING

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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.K252892SCOUT 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.K233639SmartClip Secure Soft Tissue MarkerElucent Medical, 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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