FDA 510(k)

D.O.R.C. Disposable Cryo Probe

K-Number: K160591 · 2017-01-23

ApplicantDutch Ophthalmic Research Center International BV

Decision Date2017-01-23

Product CodeHRN

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

D.O.R.C. Disposable Cryo Probe is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic Research Center International BV. It received FDA 510(k) clearance on 2017-01-23 under 510(k) number K160591. 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 D.O.R.C. Disposable Cryo Probe?

D.O.R.C. Disposable Cryo Probe is a medical device that received FDA 510(k) clearance on 2017-01-23. The listed applicant is Dutch Ophthalmic Research Center International BV. The 510(k) number is K160591.

When did D.O.R.C. Disposable Cryo Probe receive FDA 510(k) clearance?

D.O.R.C. Disposable Cryo Probe received FDA 510(k) clearance on 2017-01-23, under 510(k) number K160591.

Who is the listed applicant for D.O.R.C. Disposable Cryo Probe?

The FDA 510(k) record lists Dutch Ophthalmic Research Center International BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D.O.R.C. Disposable Cryo Probe?

The FDA product code for D.O.R.C. Disposable Cryo Probe is HRN.

Related Devices (Code: HRN)

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 AdapterPhakos K180195Frigitronics adapterPhakos K162756PHAKOS Disposable Retinal Cryo ProbePhakos

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.