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FDA 510(k)

IRRIGATION & ASPIRATION/VITRECTOMY DEVICE

K-Number: K862188 · 1986-08-21

ApplicantCoburn Optical Ind., Inc.
Decision Date1986-08-21
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRRIGATION & ASPIRATION/VITRECTOMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Coburn Optical Ind., Inc.. It received FDA 510(k) clearance on 1986-08-21 under 510(k) number K862188. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION & ASPIRATION/VITRECTOMY DEVICE?

IRRIGATION & ASPIRATION/VITRECTOMY DEVICE is a medical device that received FDA 510(k) clearance on 1986-08-21. The listed applicant is Coburn Optical Ind., Inc.. The 510(k) number is K862188.

When did IRRIGATION & ASPIRATION/VITRECTOMY DEVICE receive FDA 510(k) clearance?

IRRIGATION & ASPIRATION/VITRECTOMY DEVICE received FDA 510(k) clearance on 1986-08-21, under 510(k) number K862188.

Who is the listed applicant for IRRIGATION & ASPIRATION/VITRECTOMY DEVICE?

The FDA 510(k) record lists Coburn Optical Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRRIGATION & ASPIRATION/VITRECTOMY DEVICE?

The FDA product code for IRRIGATION & ASPIRATION/VITRECTOMY DEVICE is HQE.

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Other records listing Coburn Optical Ind., Inc. 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.

K892347MAGNILINK SYSTEM 101K892349MAGNILINK SYSTEM 209K892351MAGNILINK SYSTEM 602K892348MAGNILINK SYSTEM 201K892350MAGNILINK SYSTEM 402/5K853457COBURN I/A SYSTEM

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Related Devices (Code: HQE)

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.

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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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