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)

LIXISCOPE - OR LIXI

K-Number: K820658 · 1982-05-18

ApplicantLixi, Inc.
Decision Date1982-05-18
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIXISCOPE - OR LIXI is the device name listed in this FDA 510(k) record. The listed applicant is Lixi, Inc.. It received FDA 510(k) clearance on 1982-05-18 under 510(k) number K820658. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIXISCOPE - OR LIXI?

LIXISCOPE - OR LIXI is a medical device that received FDA 510(k) clearance on 1982-05-18. The listed applicant is Lixi, Inc.. The 510(k) number is K820658.

When did LIXISCOPE - OR LIXI receive FDA 510(k) clearance?

LIXISCOPE - OR LIXI received FDA 510(k) clearance on 1982-05-18, under 510(k) number K820658.

Who is the listed applicant for LIXISCOPE - OR LIXI?

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

What is the FDA product code for LIXISCOPE - OR LIXI?

The FDA product code for LIXISCOPE - OR LIXI is OXO.

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 Lixi, 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.

K925251LIXI IMAGING SCOPE. MODIFICATION

Related Devices (Code: OXO)

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.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, 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.

↑