Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STSTORZ DP5300 AND DP9502 STERILE DRAPES

K-Number: K934445 · 1994-04-11

ApplicantStorz Instrument Co.
Decision Date1994-04-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STSTORZ DP5300 AND DP9502 STERILE DRAPES 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 1994-04-11 under 510(k) number K934445. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STSTORZ DP5300 AND DP9502 STERILE DRAPES?

STSTORZ DP5300 AND DP9502 STERILE DRAPES is a medical device that received FDA 510(k) clearance on 1994-04-11. The listed applicant is Storz Instrument Co.. The 510(k) number is K934445.

When did STSTORZ DP5300 AND DP9502 STERILE DRAPES receive FDA 510(k) clearance?

STSTORZ DP5300 AND DP9502 STERILE DRAPES received FDA 510(k) clearance on 1994-04-11, under 510(k) number K934445.

Who is the listed applicant for STSTORZ DP5300 AND DP9502 STERILE DRAPES?

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 STSTORZ DP5300 AND DP9502 STERILE DRAPES?

The FDA product code for STSTORZ DP5300 AND DP9502 STERILE DRAPES is KKX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 101 devices →

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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.

↑