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FDA 510(k)

VERSAVIT

K-Number: K121675 · 2012-06-21

ApplicantSynergetics, Inc.
Decision Date2012-06-21
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VERSAVIT is the device name listed in this FDA 510(k) record. The listed applicant is Synergetics, Inc.. It received FDA 510(k) clearance on 2012-06-21 under 510(k) number K121675. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSAVIT?

VERSAVIT is a medical device that received FDA 510(k) clearance on 2012-06-21. The listed applicant is Synergetics, Inc.. The 510(k) number is K121675.

When did VERSAVIT receive FDA 510(k) clearance?

VERSAVIT received FDA 510(k) clearance on 2012-06-21, under 510(k) number K121675.

Who is the listed applicant for VERSAVIT?

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

What is the FDA product code for VERSAVIT?

The FDA product code for VERSAVIT is HQE.

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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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