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)

NAVIAID ICVI-F,S,B,R DEVICE

K-Number: K112106 · 2012-02-06

ApplicantSmart Medical Systems , Ltd.
Decision Date2012-02-06
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NAVIAID ICVI-F,S,B,R DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Smart Medical Systems , Ltd.. It received FDA 510(k) clearance on 2012-02-06 under 510(k) number K112106. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIAID ICVI-F,S,B,R DEVICE?

NAVIAID ICVI-F,S,B,R DEVICE is a medical device that received FDA 510(k) clearance on 2012-02-06. The listed applicant is Smart Medical Systems , Ltd.. The 510(k) number is K112106.

When did NAVIAID ICVI-F,S,B,R DEVICE receive FDA 510(k) clearance?

NAVIAID ICVI-F,S,B,R DEVICE received FDA 510(k) clearance on 2012-02-06, under 510(k) number K112106.

Who is the listed applicant for NAVIAID ICVI-F,S,B,R DEVICE?

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

What is the FDA product code for NAVIAID ICVI-F,S,B,R DEVICE?

The FDA product code for NAVIAID ICVI-F,S,B,R DEVICE is ODC.

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 Smart Medical Systems , Ltd. 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.

K220158G-EYE SystemK202469G-EYE SystemK192588G-EYE SystemK111760NAVIAID(TM) BGC DEVICEK110291NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICEK102616NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

View all 9 devices →

Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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.

↑