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FDA 510(k)

TROCASYS

K-Number: K063528 · 2007-01-17

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2007-01-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TROCASYS is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2007-01-17 under 510(k) number K063528. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROCASYS?

TROCASYS is a medical device that received FDA 510(k) clearance on 2007-01-17. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K063528.

When did TROCASYS receive FDA 510(k) clearance?

TROCASYS received FDA 510(k) clearance on 2007-01-17, under 510(k) number K063528.

Who is the listed applicant for TROCASYS?

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

What is the FDA product code for TROCASYS?

The FDA product code for TROCASYS is GCJ.

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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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