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FDA 510(k)

RE-USEABLE MICROSTAAR INJECTOR, MSI-S

K-Number: K032412 · 2004-06-10

ApplicantStaar Surgical Co.
Decision Date2004-06-10
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RE-USEABLE MICROSTAAR INJECTOR, MSI-S is the device name listed in this FDA 510(k) record. The listed applicant is Staar Surgical Co.. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K032412. 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 RE-USEABLE MICROSTAAR INJECTOR, MSI-S?

RE-USEABLE MICROSTAAR INJECTOR, MSI-S is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Staar Surgical Co.. The 510(k) number is K032412.

When did RE-USEABLE MICROSTAAR INJECTOR, MSI-S receive FDA 510(k) clearance?

RE-USEABLE MICROSTAAR INJECTOR, MSI-S received FDA 510(k) clearance on 2004-06-10, under 510(k) number K032412.

Who is the listed applicant for RE-USEABLE MICROSTAAR INJECTOR, MSI-S?

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

What is the FDA product code for RE-USEABLE MICROSTAAR INJECTOR, MSI-S?

The FDA product code for RE-USEABLE MICROSTAAR INJECTOR, MSI-S is KYB.

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Other records listing Staar Surgical Co. 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.

K090161EPIPHANY INJECTION SYSTEMK073591MICROSTAAR MSI INJECTOR FOAM TIP SYSTEMK073586MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEMK020734SURGE-FREE ASPIRATION ADAPTERK983129DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)K980696FOAM TIP INJECTOR

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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.K022723MASTEL 1 FOLDER IMPLANTATION SYSTEMMastel Precision, 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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