K160591 is an FDA 510(k) clearance for the D.O.R.C. Disposable Cryo Probe. This device is classified as a Unit, Cryophthalmic, Ac-powered (Class II - Special Controls, product code HRN).
Submitted by Dutch Ophthalmic Research Center International BV (Zuidland, NL). The FDA issued a Cleared decision on January 23, 2017, 328 days after receiving the submission on March 1, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4170.
| 510(k) Number | K160591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2016 |
| Decision Date | January 23, 2017 |
| Days to Decision | 328 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HRN — Unit, Cryophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4170 |