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FDA 510(k)

VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100

K-Number: K853961 · 1985-12-13

ApplicantVisitec Co.
Decision Date1985-12-13
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1985-12-13 under 510(k) number K853961. 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 VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100?

VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 is a medical device that received FDA 510(k) clearance on 1985-12-13. The listed applicant is Visitec Co.. The 510(k) number is K853961.

When did VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 receive FDA 510(k) clearance?

VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 received FDA 510(k) clearance on 1985-12-13, under 510(k) number K853961.

Who is the listed applicant for VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100?

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

What is the FDA product code for VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100?

The FDA product code for VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 is HQE.

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Other records listing Visitec Co. 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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTS

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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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