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FDA 510(k)

VITREONIC PLUS

K-Number: K834160 · 1986-02-07

ApplicantAmerican Surgical Co., Inc.
Decision Date1986-02-07
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VITREONIC PLUS is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Co., Inc.. It received FDA 510(k) clearance on 1986-02-07 under 510(k) number K834160. 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 VITREONIC PLUS?

VITREONIC PLUS is a medical device that received FDA 510(k) clearance on 1986-02-07. The listed applicant is American Surgical Co., Inc.. The 510(k) number is K834160.

When did VITREONIC PLUS receive FDA 510(k) clearance?

VITREONIC PLUS received FDA 510(k) clearance on 1986-02-07, under 510(k) number K834160.

Who is the listed applicant for VITREONIC PLUS?

The FDA 510(k) record lists American Surgical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITREONIC PLUS?

The FDA product code for VITREONIC PLUS 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 American Surgical Co., 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.

K834162VIT PACK841738AMER. SURGICAL CORP. EXTRA PLUS PAKK834158EXTRA SENSORY PLUSK834163ULTRAVITK833697EXTRA SENSORY PAK-DISPOS. ACCESSK833617EXTRA PLUS TM

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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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