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FDA 510(k)

DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY

K-Number: K864292 · 1986-12-29

ApplicantEye-Ko, Inc.
Decision Date1986-12-29
Product CodeHNQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Eye-Ko, Inc.. It received FDA 510(k) clearance on 1986-12-29 under 510(k) number K864292. The device is classified under product code HNQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY?

DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY is a medical device that received FDA 510(k) clearance on 1986-12-29. The listed applicant is Eye-Ko, Inc.. The 510(k) number is K864292.

When did DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY receive FDA 510(k) clearance?

DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY received FDA 510(k) clearance on 1986-12-29, under 510(k) number K864292.

Who is the listed applicant for DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY?

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

What is the FDA product code for DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY?

The FDA product code for DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY is HNQ.

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Related Devices (Code: HNQ)

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.

K030471OPHTEC ENCLAVATION NEEDLEOphtec, USAK022842STEPHENS DISPOSABLE HOOKSStephens InstrumentsK874991PRISMA DISPOSABLE IRRIGATING IRIS HOOKAdvanced Surgical Products, Inc.K870440LOOK LENS LOOPSLook, Inc.K863988THORTON TITANIUM HOOK ANGLED RIGHTKeeler Instruments, Inc.K801469BONN MICRO IRIS HOOK (NON-STERILE) #7613Edward Weck, 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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