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FDA 510(k)

CATAREX DIAP. EXTRACAPSULAR CATARACT

K-Number: K832446 · 1983-10-19

ApplicantCalliope Corp.
Decision Date1983-10-19
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CATAREX DIAP. EXTRACAPSULAR CATARACT is the device name listed in this FDA 510(k) record. The listed applicant is Calliope Corp.. It received FDA 510(k) clearance on 1983-10-19 under 510(k) number K832446. 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 CATAREX DIAP. EXTRACAPSULAR CATARACT?

CATAREX DIAP. EXTRACAPSULAR CATARACT is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Calliope Corp.. The 510(k) number is K832446.

When did CATAREX DIAP. EXTRACAPSULAR CATARACT receive FDA 510(k) clearance?

CATAREX DIAP. EXTRACAPSULAR CATARACT received FDA 510(k) clearance on 1983-10-19, under 510(k) number K832446.

Who is the listed applicant for CATAREX DIAP. EXTRACAPSULAR CATARACT?

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

What is the FDA product code for CATAREX DIAP. EXTRACAPSULAR CATARACT?

The FDA product code for CATAREX DIAP. EXTRACAPSULAR CATARACT is HQE.

Related Clinical Trials

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Other records listing Calliope Corp. 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.

K840063CATAREX VITRECUTTER I/A DISPOS. CUTK840181CATAREX/ULTRASONICS KIT

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

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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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