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)

SDI C-FLEX STERILE LIGHT HANDLE

K-Number: K834239 · 1984-04-25

ApplicantSterile Design, Inc.
Decision Date1984-04-25
Product Code
DecisionSubstantially Equivalent

Device Summary

SDI C-FLEX STERILE LIGHT HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Design, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K834239. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDI C-FLEX STERILE LIGHT HANDLE?

SDI C-FLEX STERILE LIGHT HANDLE is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Sterile Design, Inc.. The 510(k) number is K834239.

When did SDI C-FLEX STERILE LIGHT HANDLE receive FDA 510(k) clearance?

SDI C-FLEX STERILE LIGHT HANDLE received FDA 510(k) clearance on 1984-04-25, under 510(k) number K834239.

Who is the listed applicant for SDI C-FLEX STERILE LIGHT HANDLE?

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

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 Sterile Design, 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.

K934688STERILE DESIGNK841960CARDIO METRICS INVASIVE PRESSURE MONITK842356CUSTOM STERILE PROCEDURE KITSK841959CARDIO METRIC CUSTOM PERFUSION TUBINGK842351STERILE DESIGN-CUSTOM STERILE IV KITK841958CARDIO METRICS CARDIOTOMY RESERVOIR

View all 10 devices →

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.

↑