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)

MEDILASE 5010 ENDOSCOPE CONSOLE

K-Number: K900380 · 1990-05-15

ApplicantMedical Laser, Inc.
Decision Date1990-05-15
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDILASE 5010 ENDOSCOPE CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laser, Inc.. It received FDA 510(k) clearance on 1990-05-15 under 510(k) number K900380. 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 MEDILASE 5010 ENDOSCOPE CONSOLE?

MEDILASE 5010 ENDOSCOPE CONSOLE is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Medical Laser, Inc.. The 510(k) number is K900380.

When did MEDILASE 5010 ENDOSCOPE CONSOLE receive FDA 510(k) clearance?

MEDILASE 5010 ENDOSCOPE CONSOLE received FDA 510(k) clearance on 1990-05-15, under 510(k) number K900380.

Who is the listed applicant for MEDILASE 5010 ENDOSCOPE CONSOLE?

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

What is the FDA product code for MEDILASE 5010 ENDOSCOPE CONSOLE?

The FDA product code for MEDILASE 5010 ENDOSCOPE CONSOLE 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 Medical Laser, 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.

K913136LASER ENDOSCOPE DISC DECOMPRESSION KITSK912265MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000K912447SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200K912089MODIFIED SERIES 2100 ENDOSCOPESK901464MEDILASE SERIES 2200 ENDOSCOPEK900894MEDILASE SERIES 2100 ENDOSCOPE

View all 8 devices →

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.

↑