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FDA 510(k)

STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM

K-Number: K950114 · 1995-06-02

ApplicantStorz Instrument Co.
Decision Date1995-06-02
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM 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 1995-06-02 under 510(k) number K950114. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM?

STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Storz Instrument Co.. The 510(k) number is K950114.

When did STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM receive FDA 510(k) clearance?

STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM received FDA 510(k) clearance on 1995-06-02, under 510(k) number K950114.

Who is the listed applicant for STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM?

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 STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM?

The FDA product code for STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM is HQC.

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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: HQC)

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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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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