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FDA 510(k)

MFUSE (MS001)

K-Number: K250319 · 2025-12-15

ApplicantMachina Medical, Inc.
Decision Date2025-12-15
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

MFUSE (MS001) is the device name listed in this FDA 510(k) record. The listed applicant is Machina Medical, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K250319. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MFUSE (MS001)?

MFUSE (MS001) is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Machina Medical, Inc.. The 510(k) number is K250319.

When did MFUSE (MS001) receive FDA 510(k) clearance?

MFUSE (MS001) received FDA 510(k) clearance on 2025-12-15, under 510(k) number K250319.

Who is the listed applicant for MFUSE (MS001)?

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

What is the FDA product code for MFUSE (MS001)?

The FDA product code for MFUSE (MS001) is QSY.

Related Devices (Code: QSY)

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.

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmSpeciality Fibres and Materials LimitedK253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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