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FDA 510(k)

REUSABLE VITRECTOMY PROBE

K-Number: K970670 · 1997-05-06

ApplicantAltex Vision
Decision Date1997-05-06
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

REUSABLE VITRECTOMY PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Altex Vision. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K970670. 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 REUSABLE VITRECTOMY PROBE?

REUSABLE VITRECTOMY PROBE is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Altex Vision. The 510(k) number is K970670.

When did REUSABLE VITRECTOMY PROBE receive FDA 510(k) clearance?

REUSABLE VITRECTOMY PROBE received FDA 510(k) clearance on 1997-05-06, under 510(k) number K970670.

Who is the listed applicant for REUSABLE VITRECTOMY PROBE?

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

What is the FDA product code for REUSABLE VITRECTOMY PROBE?

The FDA product code for REUSABLE VITRECTOMY PROBE is HQE.

Related Clinical Trials

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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Other records listing Altex Vision 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.

K970673DISPOSABLE VITRECTOMY PROBE

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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