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FDA 510(k)

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle

K-Number: K172775 · 2018-02-12

ApplicantTeleflexmedical, Inc.
Decision Date2018-02-12
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K172775. 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 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K172775.

When did MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle receive FDA 510(k) clearance?

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle received FDA 510(k) clearance on 2018-02-12, under 510(k) number K172775.

Who is the listed applicant for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

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

What is the FDA product code for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

The FDA product code for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is 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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