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FDA 510(k)

SNM FIRMGRIP

K-Number: K092629 · 2009-09-25

ApplicantFlexicath , Ltd.
Decision Date2009-09-25
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SNM FIRMGRIP is the device name listed in this FDA 510(k) record. The listed applicant is Flexicath , Ltd.. It received FDA 510(k) clearance on 2009-09-25 under 510(k) number K092629. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SNM FIRMGRIP?

SNM FIRMGRIP is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is Flexicath , Ltd.. The 510(k) number is K092629.

When did SNM FIRMGRIP receive FDA 510(k) clearance?

SNM FIRMGRIP received FDA 510(k) clearance on 2009-09-25, under 510(k) number K092629.

Who is the listed applicant for SNM FIRMGRIP?

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

What is the FDA product code for SNM FIRMGRIP?

The FDA product code for SNM FIRMGRIP is FOZ.

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.

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Other records listing Flexicath , Ltd. 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.

K111939M/29TM - PRESSURE INJECTABLEK080793FIRMGRIPK063363FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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