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)

INSIGHT

K-Number: K811345 · 1981-07-10

ApplicantStaodynamics, Inc.
Decision Date1981-07-10
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INSIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Staodynamics, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811345. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSIGHT?

INSIGHT is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Staodynamics, Inc.. The 510(k) number is K811345.

When did INSIGHT receive FDA 510(k) clearance?

INSIGHT received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811345.

Who is the listed applicant for INSIGHT?

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

What is the FDA product code for INSIGHT?

The FDA product code for INSIGHT is GZJ.

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

Related PubMed Literature

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.

PMID: 42849513Surgical Artificial Intelligence Innovation Trends and Regulatory Insights: A Systematic Analysis of Food and Drug Administration-Approved Devices.Annals of surgery ()PMID: 42624759Bridging Early Feasibility and Pivotal Trials: Insights From Transcatheter Tricuspid Valve Interventions.Clinical therapeutics ()PMID: 42174919Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data.Studies in health technology and informatics ()PMID: 40644609Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.JMIR medical informatics ()

Other records listing Staodynamics, 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.

K852298TENS-AID STERILE ELECTRODES FOR POST-OP TENSK843964TENS-AID PREMIUM ELECTRODESK832988STAODYN EMS/PLUSK81328310D (TENS DEVICE)K813098TENS DEVICEK792501PLS MINI

View all 14 devices →

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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.

↑