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FDA 510(k)

SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11

K-Number: K850883 · 1985-03-20

ApplicantStorz Instrument Co.
Decision Date1985-03-20
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 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 1985-03-20 under 510(k) number K850883. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11?

SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 is a medical device that received FDA 510(k) clearance on 1985-03-20. The listed applicant is Storz Instrument Co.. The 510(k) number is K850883.

When did SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 receive FDA 510(k) clearance?

SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 received FDA 510(k) clearance on 1985-03-20, under 510(k) number K850883.

Who is the listed applicant for SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11?

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 SPONGE II, OLK DESIGN, E5395-10 & E5395-11?

The FDA product code for SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 is HOZ.

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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: HOZ)

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.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, 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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