D.O.R.C. Disposable Cryo Probe
FDA 510(k) K160591 · Dutch Ophthalmic Research Center International BV
510(k) numberK160591
Submission
- Device name
- D.O.R.C. Disposable Cryo Probe
- Applicant
- Dutch Ophthalmic Research Center International BV
Zuidland, NL - Received
- March 1, 2016
- Decision date
- January 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRN – Unit, Cryophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Specialty
- Ophthalmic
Other 510(k)s with product code HRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200911 | MIRA AdapterHRN · Traditional | Phakos | 06/02/2020SE |
| K180195 | Frigitronics adapterHRN · Traditional | Phakos | 03/16/2018SE |
| K162756 | PHAKOS Disposable Retinal Cryo ProbeHRN · Traditional | Phakos | 05/03/2017SE |
| K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesHRN · Special | Keeler, Ltd. | 12/23/2013SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | Keeler Instruments, Inc. | 12/08/2011SE |
| K062412 | CryomaticHRN · Traditional | Keeler Instruments, Inc. | 11/06/2006SE |
| K012821 | D.O.R.C. Cryostar Cryosurgical SystemHRN · Traditional | Dutch Ophthalmic USA, Inc. | 10/22/2001SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | Keeler Instruments, Inc. | 12/21/1999SE |
| K823768 | Clirans TE08 Hollow Fiber DialyzerHRN · Traditional | Terumo Medical Corp. | 01/08/1983SE |
More from Terumo Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC…HQC · Traditional | 03/13/2015SE |
| K081877 | Associate 2500 Dual and Compact SystemsHQC · Traditional | 01/05/2009SE |
| K062895 | Xenon Brightstar Illumination System, Model 1266.XIIIMPA · Special | 10/13/2006SE |
Questions and answers
When was D.O.R.C. Disposable Cryo Probe cleared by the FDA?
D.O.R.C. Disposable Cryo Probe (K160591) received a 510(k) decision of Substantially Equivalent on January 23, 2017, 328 days after the submission was received.
What is the product code of K160591?
The FDA product code is HRN – Unit, Cryophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4170.