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FDA 510(k)

STORZ DISPOSABLE BIPOLAR PENCILS

K-Number: K882802 · 1988-08-17

ApplicantStorz Instrument Co.
Decision Date1988-08-17
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STORZ DISPOSABLE BIPOLAR PENCILS 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 1988-08-17 under 510(k) number K882802. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STORZ DISPOSABLE BIPOLAR PENCILS?

STORZ DISPOSABLE BIPOLAR PENCILS is a medical device that received FDA 510(k) clearance on 1988-08-17. The listed applicant is Storz Instrument Co.. The 510(k) number is K882802.

When did STORZ DISPOSABLE BIPOLAR PENCILS receive FDA 510(k) clearance?

STORZ DISPOSABLE BIPOLAR PENCILS received FDA 510(k) clearance on 1988-08-17, under 510(k) number K882802.

Who is the listed applicant for STORZ DISPOSABLE BIPOLAR PENCILS?

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 DISPOSABLE BIPOLAR PENCILS?

The FDA product code for STORZ DISPOSABLE BIPOLAR PENCILS is GXI.

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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: GXI)

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.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

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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