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FDA 510(k)

KERATOME SYSTEM

K-Number: K974243 · 1998-01-20

ApplicantInsight Technologies Instruments, LLC
Decision Date1998-01-20
Product CodeHMY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KERATOME SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Insight Technologies Instruments, LLC. It received FDA 510(k) clearance on 1998-01-20 under 510(k) number K974243. The device is classified under product code HMY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERATOME SYSTEM?

KERATOME SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-20. The listed applicant is Insight Technologies Instruments, LLC. The 510(k) number is K974243.

When did KERATOME SYSTEM receive FDA 510(k) clearance?

KERATOME SYSTEM received FDA 510(k) clearance on 1998-01-20, under 510(k) number K974243.

Who is the listed applicant for KERATOME SYSTEM?

The FDA 510(k) record lists Insight Technologies Instruments, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KERATOME SYSTEM?

The FDA product code for KERATOME SYSTEM is HMY.

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 Insight Technologies Instruments, LLC 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.

K984537KERATOME SYSTEM, MODEL K3000

Related Devices (Code: HMY)

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.

K040297ONEUSE- PLUS MICROKERATOMEMoria SAK023092BD K-4000 MICROKERATOME SYSTEMBecton, Dickinson & COK022637BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOMEBecton, Dickinson & COK022560M2 SINGLE USE MICROKERTOMEMoria SAK003594CARRIAZO BARRAQUER SINGLE USE MICROKERATOMEMoria, Inc.K002191CARRIAZO BARRAQUER II MICROKERATOMEMoria, 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.

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