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Medical device manufacturer

Storz Instrument Co.

Storz Instrument Co. holds 101 FDA 510(k) clearances across 46 product codes. Median elapsed review time is 76 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
101
Product codes
46
Median review
76 days
Recall records
0

How does FDA spell Storz Instrument Co.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Storz Instrument Co. file in?

46 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
HQCUnit, Phacofragmentation1785 days
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered1684 days
IYOSystem, Imaging, Pulsed Echo, Ultrasonic765 days
EPTMicroscope, Surgical431 days
GEIElectrosurgical, Cutting & Coagulation & Accessories451 days
HBIIlluminator, Fiberoptic, Surgical Field390 days
HNNKnife, Ophthalmic378 days
HNOKeratome, Ac-Powered372 days
GXIProbe, Radiofrequency Lesion241 days
GXWEchoencephalograph24 days
HMXCannula, Ophthalmic224 days
HNRForceps, Ophthalmic235 days
HQNConformer, Ophthalmic288 days
HRSPlate, Fixation, Bone243 days
BTAPump, Portable, Aspiration (Manual Or Powered)160 days
EFQGauze/Sponge, Internal122 days
EOBNasopharyngoscope (Flexible Or Rigid)183 days
ETYTester, Auditory Impedance1309 days
FCWLight Source, Fiberoptic, Routine154 days
FSMTray, Surgical, Instrument183 days
FWLCamera, Cine, Endoscopic, Without Audio122 days
GBBChair, Surgical, Ac-Powered118 days
GBXCatheter, Irrigation179 days
GCJLaparoscope, General & Plastic Surgery174 days
GDMNeedle, Aspiration And Injection, Reusable163 days

Showing the 25 they file in most, of 46.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Storz Instrument Co. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Storz Instrument Co. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K980100STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACKMSR140
K980488STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEMHQE42
K972664STORZ MILLENNIUM VISCOUS FLUID SYSTEMMRH86
K971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLESHQC60
K964743STORZ E8010 ERGOTEC/PREMIERE ADAPTORHQE69
K960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHHQC262
K960061STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBEHQE258
K960003STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSIONHQC240
K962131STORZ D4600 AIR EXCHANGE LINE PACKHQC81
K961874STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACKHQC83

Source: openFDA device/510k · retrieved

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.