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)

TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM

K-Number: K031786 · 2003-08-05

ApplicantVision-Sciences, Inc.
Decision Date2003-08-05
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vision-Sciences, Inc.. It received FDA 510(k) clearance on 2003-08-05 under 510(k) number K031786. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM?

TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-05. The listed applicant is Vision-Sciences, Inc.. The 510(k) number is K031786.

When did TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM receive FDA 510(k) clearance?

TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM received FDA 510(k) clearance on 2003-08-05, under 510(k) number K031786.

Who is the listed applicant for TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM?

The FDA 510(k) record lists Vision-Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM?

The FDA product code for TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM is EOX.

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 Vision-Sciences, 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.

K102733VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSORK100125VISION SCIENCES FLEXIBLE ENT SCOPEK091768VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIESK072180VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEMK071127FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEMK072088FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS

View all 33 devices →

Related Devices (Code: EOX)

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.

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted LimitedK230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.

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.

↑