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FDA 510(k)

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+

K-Number: K170520 · 2017-03-22

ApplicantAlcon Research, Ltd.
Decision Date2017-03-22
Product CodeMLZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Research, Ltd.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K170520. The device is classified under product code MLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Alcon Research, Ltd.. The 510(k) number is K170520.

When did HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ receive FDA 510(k) clearance?

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ received FDA 510(k) clearance on 2017-03-22, under 510(k) number K170520.

Who is the listed applicant for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

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

What is the FDA product code for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+?

The FDA product code for HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ is MLZ.

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Related Devices (Code: MLZ)

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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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