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FDA 510(k)

SPEEDTRAP Graft Preparation System

K-Number: K161638 · 2016-11-07

ApplicantMedos International SARL
Decision Date2016-11-07
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPEEDTRAP Graft Preparation System is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K161638. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEEDTRAP Graft Preparation System?

SPEEDTRAP Graft Preparation System is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Medos International SARL. The 510(k) number is K161638.

When did SPEEDTRAP Graft Preparation System receive FDA 510(k) clearance?

SPEEDTRAP Graft Preparation System received FDA 510(k) clearance on 2016-11-07, under 510(k) number K161638.

Who is the listed applicant for SPEEDTRAP Graft Preparation System?

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

What is the FDA product code for SPEEDTRAP Graft Preparation System?

The FDA product code for SPEEDTRAP Graft Preparation System is GAT.

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Related Devices (Code: GAT)

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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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