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FDA 510(k)

MAID MENTOR ASPIRATION/IRRIGATION DEVRO

K-Number: K853382 · 1985-10-04

ApplicantMentor O & O, Inc.
Decision Date1985-10-04
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAID MENTOR ASPIRATION/IRRIGATION DEVRO is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853382. 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 MAID MENTOR ASPIRATION/IRRIGATION DEVRO?

MAID MENTOR ASPIRATION/IRRIGATION DEVRO is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K853382.

When did MAID MENTOR ASPIRATION/IRRIGATION DEVRO receive FDA 510(k) clearance?

MAID MENTOR ASPIRATION/IRRIGATION DEVRO received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853382.

Who is the listed applicant for MAID MENTOR ASPIRATION/IRRIGATION DEVRO?

The FDA 510(k) record lists Mentor O & O, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAID MENTOR ASPIRATION/IRRIGATION DEVRO?

The FDA product code for MAID MENTOR ASPIRATION/IRRIGATION DEVRO is HQE.

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Other records listing Mentor O & O, Inc. as applicant

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K955245MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEMK934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONK912904MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEMK915340MENTOR HORIZON LOW VISION MAGNIFIERK910637MENTOR(R) SUR-E-TROL(R)K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305

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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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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