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FDA 510(k)

SCLERAL BUCKLING IMPLANTS DIF/TYPES

K-Number: K832481 · 1983-09-20

ApplicantStorz Instrument Co.
Decision Date1983-09-20
Product CodeHQX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCLERAL BUCKLING IMPLANTS DIF/TYPES is the device name listed in this FDA 510(k) record. The listed applicant is Storz Instrument Co.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832481. 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 SCLERAL BUCKLING IMPLANTS DIF/TYPES?

SCLERAL BUCKLING IMPLANTS DIF/TYPES is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Storz Instrument Co.. The 510(k) number is K832481.

When did SCLERAL BUCKLING IMPLANTS DIF/TYPES receive FDA 510(k) clearance?

SCLERAL BUCKLING IMPLANTS DIF/TYPES received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832481.

Who is the listed applicant for SCLERAL BUCKLING IMPLANTS DIF/TYPES?

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

What is the FDA product code for SCLERAL BUCKLING IMPLANTS DIF/TYPES?

The FDA product code for SCLERAL BUCKLING IMPLANTS DIF/TYPES is HQX.

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Other records listing Storz Instrument 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.

K980100STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACKK980488STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEMK972664STORZ MILLENNIUM VISCOUS FLUID SYSTEMK971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLESK964743STORZ E8010 ERGOTEC/PREMIERE ADAPTORK960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH

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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

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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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