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)

KARL STORZ OPTICAL MEDIASTINOSCOPE

K-Number: K954910 · 1995-11-03

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1995-11-03
Product CodeEWY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KARL STORZ OPTICAL MEDIASTINOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1995-11-03 under 510(k) number K954910. The device is classified under product code EWY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ OPTICAL MEDIASTINOSCOPE?

KARL STORZ OPTICAL MEDIASTINOSCOPE is a medical device that received FDA 510(k) clearance on 1995-11-03. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K954910.

When did KARL STORZ OPTICAL MEDIASTINOSCOPE receive FDA 510(k) clearance?

KARL STORZ OPTICAL MEDIASTINOSCOPE received FDA 510(k) clearance on 1995-11-03, under 510(k) number K954910.

Who is the listed applicant for KARL STORZ OPTICAL MEDIASTINOSCOPE?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ OPTICAL MEDIASTINOSCOPE?

The FDA product code for KARL STORZ OPTICAL MEDIASTINOSCOPE is EWY.

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-America, Inc. 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

View all 355 devices →

Related Devices (Code: EWY)

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.

K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KGK213194HD MediastinoscopeKarl Storz Endoscopy America, Inc.K202272HD MediastinoscopeKarl Storz Endoscopy America, Inc.K170757Aegis Transit SystemBoston-Biomedical AssociatesK160171Illuminated Mediastinal Access PortAegis Surgical, Ltd.K971166OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECERichard Wolf Medical Instruments Corp.

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.

↑