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FDA 510(k)

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

K-Number: K120524 · 2012-06-21

ApplicantMui Scientific
Decision Date2012-06-21
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mui Scientific. It received FDA 510(k) clearance on 2012-06-21 under 510(k) number K120524. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM?

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-21. The listed applicant is Mui Scientific. The 510(k) number is K120524.

When did SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM receive FDA 510(k) clearance?

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM received FDA 510(k) clearance on 2012-06-21, under 510(k) number K120524.

Who is the listed applicant for SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM?

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

What is the FDA product code for SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM?

The FDA product code for SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM is FFX.

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Other records listing Mui Scientific 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.

K160287Rapid Barostat Bag (RBB) Pump and CatheterK122294PRESSURIZED INFUSION PUMPK823701MOTILITY CATHETERS

Related Devices (Code: FFX)

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.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx Robotica Corp

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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