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FDA 510(k)

AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE

K-Number: K860891 · 1986-04-21

ApplicantIntra-Optics Labs. C/O Newman Assoc.
Decision Date1986-04-21
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Intra-Optics Labs. C/O Newman Assoc.. It received FDA 510(k) clearance on 1986-04-21 under 510(k) number K860891. 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 AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE?

AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE is a medical device that received FDA 510(k) clearance on 1986-04-21. The listed applicant is Intra-Optics Labs. C/O Newman Assoc.. The 510(k) number is K860891.

When did AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE receive FDA 510(k) clearance?

AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE received FDA 510(k) clearance on 1986-04-21, under 510(k) number K860891.

Who is the listed applicant for AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE?

The FDA 510(k) record lists Intra-Optics Labs. C/O Newman Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE?

The FDA product code for AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE is HQE.

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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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