D.O.R.C. Disposable Cryo Probe
K-Number: K160591 · 2017-01-23
Decision Date2017-01-23
Product CodeHRN
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
D.O.R.C. Disposable Cryo Probe is a medical device manufactured by Dutch Ophthalmic Research Center International BV. It received FDA 510(k) clearance on 2017-01-23 under approval 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. It is manufactured by Dutch Ophthalmic Research Center International BV. The 510(k) number is K160591.
When was D.O.R.C. Disposable Cryo Probe approved by the FDA?
D.O.R.C. Disposable Cryo Probe received FDA 510(k) clearance on 2017-01-23, under approval number K160591.
What company makes D.O.R.C. Disposable Cryo Probe?
D.O.R.C. Disposable Cryo Probe is manufactured by Dutch Ophthalmic Research Center International BV.
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)
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.