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FDA 510(k)

VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS

K-Number: K945172 · 1995-01-17

ApplicantVisitec Co.
Decision Date1995-01-17
Product CodeHQX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1995-01-17 under 510(k) number K945172. The device is classified under product code HQX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS?

VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Visitec Co.. The 510(k) number is K945172.

When did VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS receive FDA 510(k) clearance?

VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS received FDA 510(k) clearance on 1995-01-17, under 510(k) number K945172.

Who is the listed applicant for VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS?

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 SILICONE RETINAL IMPLANTS/EXPLANTS?

The FDA product code for VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS is HQX.

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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 DRAPEK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTSK940210VISITEC EYE PAD

View all 49 devices →

Related Devices (Code: HQX)

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.

K023481MICROVISION SCLERAL BUCKLING COMPONENTSMicrovision, Inc.K983581OCU-GUARD AND OCU-GUARD SUPPLEBio-Vascular, Inc.K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGESFci Ophthalmics, Inc.K963219RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGESFci Ophthalmics, Inc.K950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSMira, Inc.K950599STORS SCLERAL SPONGE II (LINCOFF DESIGN)Storz Ophthalmics, 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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