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)

PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI

K-Number: K013337 · 2001-12-13

ApplicantSurgin, Inc.
Decision Date2001-12-13
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI is the device name listed in this FDA 510(k) record. The listed applicant is Surgin, Inc.. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K013337. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI?

PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is Surgin, Inc.. The 510(k) number is K013337.

When did PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI receive FDA 510(k) clearance?

PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI received FDA 510(k) clearance on 2001-12-13, under 510(k) number K013337.

Who is the listed applicant for PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI?

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

What is the FDA product code for PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI?

The FDA product code for PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI is HNO.

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

Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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.

↑