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FDA 510(k)

DISPOSABLE MICROSTAAR INJECTOR

K-Number: K940593 · 1994-09-19

ApplicantStaar Sugical
Decision Date1994-09-19
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MICROSTAAR INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Staar Sugical. It received FDA 510(k) clearance on 1994-09-19 under 510(k) number K940593. 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 DISPOSABLE MICROSTAAR INJECTOR?

DISPOSABLE MICROSTAAR INJECTOR is a medical device that received FDA 510(k) clearance on 1994-09-19. The listed applicant is Staar Sugical. The 510(k) number is K940593.

When did DISPOSABLE MICROSTAAR INJECTOR receive FDA 510(k) clearance?

DISPOSABLE MICROSTAAR INJECTOR received FDA 510(k) clearance on 1994-09-19, under 510(k) number K940593.

Who is the listed applicant for DISPOSABLE MICROSTAAR INJECTOR?

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

What is the FDA product code for DISPOSABLE MICROSTAAR INJECTOR?

The FDA product code for DISPOSABLE MICROSTAAR INJECTOR is KYB.

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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

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

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