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FDA 510(k)

STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES

K-Number: K971439 · 1997-06-17

ApplicantStorz Instrument Co.
Decision Date1997-06-17
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES 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 1997-06-17 under 510(k) number K971439. 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 STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES?

STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Storz Instrument Co.. The 510(k) number is K971439.

When did STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES receive FDA 510(k) clearance?

STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES received FDA 510(k) clearance on 1997-06-17, under 510(k) number K971439.

Who is the listed applicant for STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES?

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 STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES?

The FDA product code for STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES is HQC.

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Other records listing Storz Instrument Co. as applicant

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K980100STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACKK980488STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEMK972664STORZ MILLENNIUM VISCOUS FLUID SYSTEMK964743STORZ E8010 ERGOTEC/PREMIERE ADAPTORK960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHK960061STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE

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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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