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FDA 510(k)

MaxTack™ Motorized Fixation Device

K-Number: K231240 · 2023-09-08

ApplicantCovidien
Decision Date2023-09-08
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MaxTack™ Motorized Fixation Device is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231240. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MaxTack™ Motorized Fixation Device?

MaxTack™ Motorized Fixation Device is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Covidien. The 510(k) number is K231240.

When did MaxTack™ Motorized Fixation Device receive FDA 510(k) clearance?

MaxTack™ Motorized Fixation Device received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231240.

Who is the listed applicant for MaxTack™ Motorized Fixation Device?

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

What is the FDA product code for MaxTack™ Motorized Fixation Device?

The FDA product code for MaxTack™ Motorized Fixation Device is OCW.

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.

NCT06710795AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia RepairACTIVE_NOT_RECRUITING

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Related Devices (Code: OCW)

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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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