Product code HRN— Ophthalmic
CLIRANS TE08 HOLLOW FIBER DIALYZER
- Classification name
- Unit, Cryophthalmic, Ac-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 886.4170
- Advisory panel
- Ophthalmic
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code HRN
FDA has cleared devices under product code HRN between 1983 and 2020, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 2018
- 2017
- 2013
- 2011
- 2006
- 2001
- 1999
- 1983
Top applicants under product code HRN
Recent clearances under product code HRN
- K200911 — MIRA Adapter
- K180195 — Frigitronics adapter
- K162756 — PHAKOS Disposable Retinal Cryo Probe
- K160591 — D.O.R.C. Disposable Cryo Probe
- K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
- K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
- K062412 — CRYOMATIC
- K012821 — D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
- K992954 — KEELER CRYO MASTER & PROBES
- K823768 — CLIRANS TE08 HOLLOW FIBER DIALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.