Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes
FDA 510(k) K131787 · Keeler, Ltd.
510(k) numberK131787
Submission
- Device name
- Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes
- Applicant
- Keeler, Ltd.
Broomall, PA, US - Received
- June 18, 2013
- Decision date
- December 23, 2013
- 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 |
| 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 |
|---|---|---|
| K152644 | Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100HKY · Special | 12/31/2015SE |
| K151394 | Keeler Slit LampHJO · Traditional | 09/10/2015SE |
| K142179 | D-Kat Z-YpeHKY · Special | 09/17/2014SE |
| K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series…HJO · Traditional | 07/11/2014SE |
| K140450 | Keeler Kapture SoftwareHKI · Traditional | 06/17/2014SE |
| K133234 | T-Type D-Kat, R-Type D-KatHKY · Traditional | 02/21/2014SE |
| K131589 | Keeler Slit Lamp H-SeriesHJO · Abbreviated | 06/27/2013SE |
| K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)HKY · Abbreviated | 01/19/2010SE |
Questions and answers
When was Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes cleared by the FDA?
Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes (K131787) received a 510(k) decision of Substantially Equivalent on December 23, 2013, 188 days after the submission was received.
What is the product code of K131787?
The FDA product code is HRN – Unit, Cryophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4170.