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FDA 510(k)

KRATZ NOVA SERT(TM)

K-Number: K883489 · 1988-10-25

ApplicantCoopervision-Cilco
Decision Date1988-10-25
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KRATZ NOVA SERT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Coopervision-Cilco. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K883489. The device is classified under product code KYB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRATZ NOVA SERT(TM)?

KRATZ NOVA SERT(TM) is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Coopervision-Cilco. The 510(k) number is K883489.

When did KRATZ NOVA SERT(TM) receive FDA 510(k) clearance?

KRATZ NOVA SERT(TM) received FDA 510(k) clearance on 1988-10-25, under 510(k) number K883489.

Who is the listed applicant for KRATZ NOVA SERT(TM)?

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

What is the FDA product code for KRATZ NOVA SERT(TM)?

The FDA product code for KRATZ NOVA SERT(TM) is KYB.

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 Coopervision-Cilco 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.

K882805CILCO VILLASENOR PACHYMETER

Related Devices (Code: KYB)

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.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786Duckworth & Kent, Ltd.K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.K070669IOL INJECTOR SETMedicel AGK063155MONARCH III IOL DELIVERY SYSTEMAlcon Manufacturing, Ltd.K063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.

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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