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)

5 STAR MEDICAL ENDOSCOPE

K-Number: K963354 · 1997-09-08

ApplicantFive Star Medical, Inc.
Decision Date1997-09-08
Product CodeODF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

5 STAR MEDICAL ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Five Star Medical, Inc.. It received FDA 510(k) clearance on 1997-09-08 under 510(k) number K963354. The device is classified under product code ODF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5 STAR MEDICAL ENDOSCOPE?

5 STAR MEDICAL ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1997-09-08. The listed applicant is Five Star Medical, Inc.. The 510(k) number is K963354.

When did 5 STAR MEDICAL ENDOSCOPE receive FDA 510(k) clearance?

5 STAR MEDICAL ENDOSCOPE received FDA 510(k) clearance on 1997-09-08, under 510(k) number K963354.

Who is the listed applicant for 5 STAR MEDICAL ENDOSCOPE?

The FDA 510(k) record lists Five Star Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5 STAR MEDICAL ENDOSCOPE?

The FDA product code for 5 STAR MEDICAL ENDOSCOPE is ODF.

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 Five Star Medical, 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.

K960876FIVE STAR BRONCHOSCOPE

Related Devices (Code: ODF)

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.

K092739MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILEC-Link Micro Imaging, Inc.K091962POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200Lumenis, Inc.K090170SPYSCOPE ACCESS AND DELIVERY CATHETERBoston Scientific CorpK052194SPYGLASS DIRECT VISUALIZATION PROBE AND OCULARBoston Scientific CorpK050403SPYGLASS DIRECT VISULATION PROBEBoston Scientific CorpK943593SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEMOvamed 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.

↑