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FDA 510(k)

PREPEX SYSTEM

K-Number: K103695 · 2012-01-10

ApplicantCirc Medtech
Decision Date2012-01-10
Product CodeHFX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PREPEX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Circ Medtech. It received FDA 510(k) clearance on 2012-01-10 under 510(k) number K103695. The device is classified under product code HFX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREPEX SYSTEM?

PREPEX SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-10. The listed applicant is Circ Medtech. The 510(k) number is K103695.

When did PREPEX SYSTEM receive FDA 510(k) clearance?

PREPEX SYSTEM received FDA 510(k) clearance on 2012-01-10, under 510(k) number K103695.

Who is the listed applicant for PREPEX SYSTEM?

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

What is the FDA product code for PREPEX SYSTEM?

The FDA product code for PREPEX SYSTEM is HFX.

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Related Devices (Code: HFX)

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Official Source

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