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 the device name listed in this FDA 510(k) record. The listed applicant is Phakos. It received FDA 510(k) clearance on 2017-05-03 under 510(k) 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. The listed applicant is Phakos. The 510(k) number is K162756.

When did PHAKOS Disposable Retinal Cryo Probe receive FDA 510(k) clearance?

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

Who is the listed applicant for PHAKOS Disposable Retinal Cryo Probe?

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

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 records listing Phakos as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200911MIRA Adapter K173944Endocular Viewing Lenses and Silicone Ring K180195Frigitronics adapter

Related Devices (Code: HRN)

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

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.