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)

SERIES 400 GASTROENTEROLOGY SYSTEM

K-Number: K944620 · 1995-04-27

ApplicantMarks & Murase
Decision Date1995-04-27
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SERIES 400 GASTROENTEROLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Marks & Murase. It received FDA 510(k) clearance on 1995-04-27 under 510(k) number K944620. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 400 GASTROENTEROLOGY SYSTEM?

SERIES 400 GASTROENTEROLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-27. The listed applicant is Marks & Murase. The 510(k) number is K944620.

When did SERIES 400 GASTROENTEROLOGY SYSTEM receive FDA 510(k) clearance?

SERIES 400 GASTROENTEROLOGY SYSTEM received FDA 510(k) clearance on 1995-04-27, under 510(k) number K944620.

Who is the listed applicant for SERIES 400 GASTROENTEROLOGY SYSTEM?

The FDA 510(k) record lists Marks & Murase as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIES 400 GASTROENTEROLOGY SYSTEM?

The FDA product code for SERIES 400 GASTROENTEROLOGY SYSTEM is FET.

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 Marks & Murase 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.

K950417EPX-310 VIDEO PROCESSOR (ENDOSCOPY)K934422NASOPHARYNGOSCOPE

Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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.

↑