Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM

K-Number: K012821 · 2001-10-22

ApplicantDutch Ophthalmic USA, Inc.
Decision Date2001-10-22
Product CodeHRN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic USA, Inc.. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K012821. The device is classified under product code HRN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM?

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Dutch Ophthalmic USA, Inc.. The 510(k) number is K012821.

When did D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM receive FDA 510(k) clearance?

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM received FDA 510(k) clearance on 2001-10-22, under 510(k) number K012821.

Who is the listed applicant for D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM?

The FDA 510(k) record lists Dutch Ophthalmic USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM?

The FDA product code for D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM is HRN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dutch Ophthalmic USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010082D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEMK983797D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEMK980636FIBER OPTIC ENDOILLUMINATION PROBEK973229D.O.R.C. HEXON ILLUMINATION SYSTEMK973757D.O.R.C. SOLUX LIGHT SOURCEK962135D.O.R.C. MICRODIATHERMY SYSTEM

View all 10 devices →

Related Devices (Code: HRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200911MIRA AdapterPhakosK180195Frigitronics adapterPhakosK162756PHAKOS Disposable Retinal Cryo ProbePhakosK160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BVK131787CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESKeeler, Ltd.K112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERKeeler Instruments, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑