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FDA 510(k)

DEXTRA DISPOSABLE BLADES

K-Number: K863867 · 1986-10-24

ApplicantStorz Instrument Co.
Decision Date1986-10-24
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEXTRA DISPOSABLE BLADES 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 1986-10-24 under 510(k) number K863867. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXTRA DISPOSABLE BLADES?

DEXTRA DISPOSABLE BLADES is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Storz Instrument Co.. The 510(k) number is K863867.

When did DEXTRA DISPOSABLE BLADES receive FDA 510(k) clearance?

DEXTRA DISPOSABLE BLADES received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863867.

Who is the listed applicant for DEXTRA DISPOSABLE BLADES?

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 DEXTRA DISPOSABLE BLADES?

The FDA product code for DEXTRA DISPOSABLE BLADES is GES.

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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: GES)

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.

K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories

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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