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FDA 510(k)

PHAKOS Disposable Retinal Cryo Probe

K-Number: K162756 · 2017-05-03

ApplicantPhakos
Decision Date2017-05-03
Product CodeHRN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHAKOS Disposable Retinal Cryo Probe is a medical device manufactured by Phakos. It received FDA 510(k) clearance on 2017-05-03 under approval number K162756. The device is classified under product code HRN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHAKOS Disposable Retinal Cryo Probe?

PHAKOS Disposable Retinal Cryo Probe is a medical device that received FDA 510(k) clearance on 2017-05-03. It is manufactured by Phakos. The 510(k) number is K162756.

When was PHAKOS Disposable Retinal Cryo Probe approved by the FDA?

PHAKOS Disposable Retinal Cryo Probe received FDA 510(k) clearance on 2017-05-03, under approval number K162756.

What company makes PHAKOS Disposable Retinal Cryo Probe?

PHAKOS Disposable Retinal Cryo Probe is manufactured by Phakos.

What is the FDA product code for PHAKOS Disposable Retinal Cryo Probe?

The FDA product code for PHAKOS Disposable Retinal Cryo Probe is HRN.

Other Devices by Phakos

K173944Endocular Viewing Lenses and Silicone Ring K180195Frigitronics adapter K200911MIRA Adapter

Related Devices (Code: HRN)

K160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV K180195Frigitronics adapterPhakos K200911MIRA AdapterPhakos

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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