Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter
FDA 510(k) K112093 · Keeler Instruments, Inc.
510(k) numberK112093
Submission
- Device name
- Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- July 22, 2011
- Decision date
- December 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K160591 | D.O.R.C. Disposable Cryo ProbeHRN · Traditional | Dutch Ophthalmic Research Center International BV | 01/23/2017SE |
| K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesHRN · Special | Keeler, Ltd. | 12/23/2013SE |
| 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 |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
| K970029 | Keeler Spectra Indirect OphthalmoscopeHLJ · Traditional | 04/02/1997SE |
Questions and answers
When was Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter cleared by the FDA?
Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter (K112093) received a 510(k) decision of Substantially Equivalent on December 8, 2011, 139 days after the submission was received.
What is the product code of K112093?
The FDA product code is HRN – Unit, Cryophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4170.