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)

OMNISONIC ENDOSCOPIC DEFLECTOR

K-Number: K993445 · 1999-12-06

ApplicantOmnisonics Medical Technologies
Decision Date1999-12-06
Product CodeGCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNISONIC ENDOSCOPIC DEFLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Omnisonics Medical Technologies. It received FDA 510(k) clearance on 1999-12-06 under 510(k) number K993445. The device is classified under product code GCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNISONIC ENDOSCOPIC DEFLECTOR?

OMNISONIC ENDOSCOPIC DEFLECTOR is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is Omnisonics Medical Technologies. The 510(k) number is K993445.

When did OMNISONIC ENDOSCOPIC DEFLECTOR receive FDA 510(k) clearance?

OMNISONIC ENDOSCOPIC DEFLECTOR received FDA 510(k) clearance on 1999-12-06, under 510(k) number K993445.

Who is the listed applicant for OMNISONIC ENDOSCOPIC DEFLECTOR?

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

What is the FDA product code for OMNISONIC ENDOSCOPIC DEFLECTOR?

The FDA product code for OMNISONIC ENDOSCOPIC DEFLECTOR is GCM.

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 Omnisonics Medical Technologies 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.

K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEMK071762OMNIWAVE ENDOVASCULAR SYSTEMK052428RESOLUTION ENDOVASCULAR SYSTEMK041705RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2K003824OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIK993628OMNISONICS ULTRASONIC PROBES

View all 8 devices →

Related Devices (Code: GCM)

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.

K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MMRichard Wolf Medical Instruments CorporationK083840MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPEMsi Medserv International Deutschland GmbHK001217INSIDE VIEWMonadnock Optics, Inc.K993103ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREESRichard Wolf Medical Instruments Corp.K962393KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATIONKARL STORZ Endoscopy-America, Inc.K950712PORTABLE ENDOSCOPY SYSTEMLaser-Optik-Systeme GmbH & Co. KG

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.

↑