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FDA 510(k)

VISITEC VITRECTOMY UNIT

K-Number: K896622 · 1990-04-04

ApplicantVisitec Co.
Decision Date1990-04-04
Product CodeHKP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISITEC VITRECTOMY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1990-04-04 under 510(k) number K896622. The device is classified under product code HKP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISITEC VITRECTOMY UNIT?

VISITEC VITRECTOMY UNIT is a medical device that received FDA 510(k) clearance on 1990-04-04. The listed applicant is Visitec Co.. The 510(k) number is K896622.

When did VISITEC VITRECTOMY UNIT receive FDA 510(k) clearance?

VISITEC VITRECTOMY UNIT received FDA 510(k) clearance on 1990-04-04, under 510(k) number K896622.

Who is the listed applicant for VISITEC VITRECTOMY UNIT?

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 VITRECTOMY UNIT?

The FDA product code for VISITEC VITRECTOMY UNIT is HKP.

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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: HKP)

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.

K952558AARON VAC 2Aaron Medical IndustriesK950056THE GRIESHABER AXIAL CUTTERGrieshaber & Co.K950287UNIVIT PROBEMedical Instrument Development Laboratories, Inc.K890595MENTOR ANTERIOR SEGMENT VITRECTORMentor O & O, Inc.K832074CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRACooperVision, Inc.K822599KEATES I/A SYSTEM FRIGITRONICS 4000Frigitronics of Connecticut, 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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