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FDA 510(k)

FIRMGRIP

K-Number: K080793 · 2008-10-16

ApplicantFlexicath , Ltd.
Decision Date2008-10-16
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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 2008-10-16 under 510(k) number K080793. 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 FIRMGRIP?

FIRMGRIP is a medical device that received FDA 510(k) clearance on 2008-10-16. The listed applicant is Flexicath , Ltd.. The 510(k) number is K080793.

When did FIRMGRIP receive FDA 510(k) clearance?

FIRMGRIP received FDA 510(k) clearance on 2008-10-16, under 510(k) number K080793.

Who is the listed applicant for 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 FIRMGRIP?

The FDA product code for 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 INJECTABLEK092629SNM FIRMGRIPK063363FIRMGRIP 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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