CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
FDA 510(k) clearance K112093 · decided 2011-12-08
Clearance details
- K-number
- K112093
- Device name
- CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
- Applicant
- Keeler Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-22
- Decision date
- 2011-12-08
- Days to decision
- 139 days
- Clearance type
- Special
- Product code
- HRN
- Device class
- 2
- Regulation number
- 886.4170
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Broomall, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MIRA Adapter (K200911) | Phakos | 2020-06-02 |
| Frigitronics adapter (K180195) | Phakos | 2018-03-16 |
| PHAKOS Disposable Retinal Cryo Probe (K162756) | Phakos | 2017-05-03 |
| D.O.R.C. Disposable Cryo Probe (K160591) | Dutch Ophthalmic Research Center International BV | 2017-01-23 |
| CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES (K131787) | Keeler, Ltd. | 2013-12-23 |
| CRYOMATIC (K062412) | Keeler Instruments, Inc. | 2006-11-06 |
| D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (K012821) | Dutch Ophthalmic USA, Inc. | 2001-10-22 |
| KEELER CRYO MASTER & PROBES (K992954) | Keeler Instruments, Inc. | 1999-12-21 |
| CLIRANS TE08 HOLLOW FIBER DIALYZER (K823768) | Terumo Medical Corp. | 1983-01-08 |
Recalls involving this device
No recalls on record reference this clearance.