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)

KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110

K-Number: K981458 · 1998-05-20

ApplicantKarl Storz Endoscopy
Decision Date1998-05-20
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K981458. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110?

KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K981458.

When did KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 receive FDA 510(k) clearance?

KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 received FDA 510(k) clearance on 1998-05-20, under 510(k) number K981458.

Who is the listed applicant for KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110?

The FDA 510(k) record lists Karl Storz Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110?

The FDA product code for KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 is EOB.

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 Karl Storz Endoscopy 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.

K043375FISCH TITANIUM MIDDLE EAR PROSTHESESK030848PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIXK030009KSEA POWERSHAVER SYSTEM S2K023924AUTOCON II 200 ELECTROSURGICAL GENERATORK023187KSEA SPINOSCOPEK011700MODULITH SLK LITHOTRIPTER

View all 35 devices →

Related Devices (Code: EOB)

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.

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KGK261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, 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.

↑