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)

CORNEA PERSERVATION UNIT

K-Number: K821170 · 1982-07-14

ApplicantXytex Corp.
Decision Date1982-07-14
Product CodeLYX
DecisionSubstantially Equivalent

Device Summary

CORNEA PERSERVATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Xytex Corp.. It received FDA 510(k) clearance on 1982-07-14 under 510(k) number K821170. The device is classified under product code LYX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORNEA PERSERVATION UNIT?

CORNEA PERSERVATION UNIT is a medical device that received FDA 510(k) clearance on 1982-07-14. The listed applicant is Xytex Corp.. The 510(k) number is K821170.

When did CORNEA PERSERVATION UNIT receive FDA 510(k) clearance?

CORNEA PERSERVATION UNIT received FDA 510(k) clearance on 1982-07-14, under 510(k) number K821170.

Who is the listed applicant for CORNEA PERSERVATION UNIT?

The FDA 510(k) record lists Xytex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORNEA PERSERVATION UNIT?

The FDA product code for CORNEA PERSERVATION UNIT is LYX.

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 Xytex Corp. 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.

K810400GLYCERINE DEHYDRATION UNIT

Related Devices (Code: LYX)

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.

K251320XTRA4Al.Chi.Mi.A. S.R.LK221759CornisolAurolabK211786Independent Corneal Viewing Chamber (IVC-21)Bausch + Lomb, IncorporatedK162013Eusol-CAl.Chi.Mi.A. S.R.LK063304LIFE4CNumedis, Inc.K063617EUSOL-CAl.Chi.Mi.A

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.

↑