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)

IOP8 INTRA OPERATIVE PROBE

K-Number: K032315 · 2004-11-18

ApplicantHuntleigh Healthcare, Inc.
Decision Date2004-11-18
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IOP8 INTRA OPERATIVE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare, Inc.. It received FDA 510(k) clearance on 2004-11-18 under 510(k) number K032315. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IOP8 INTRA OPERATIVE PROBE?

IOP8 INTRA OPERATIVE PROBE is a medical device that received FDA 510(k) clearance on 2004-11-18. The listed applicant is Huntleigh Healthcare, Inc.. The 510(k) number is K032315.

When did IOP8 INTRA OPERATIVE PROBE receive FDA 510(k) clearance?

IOP8 INTRA OPERATIVE PROBE received FDA 510(k) clearance on 2004-11-18, under 510(k) number K032315.

Who is the listed applicant for IOP8 INTRA OPERATIVE PROBE?

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

What is the FDA product code for IOP8 INTRA OPERATIVE PROBE?

The FDA product code for IOP8 INTRA OPERATIVE PROBE is ITX.

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 Huntleigh Healthcare, 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.

K022786DVT60K010744FLOWTRON UNIVERSAL, MODEL AC600K012008STS RANGE , MODELS STS20,STS30,STS40K002186VASCULAR ASSISTK010889BABY DOPPLEX 3000 MK 2 (BD3000)K010894BABY DOPPLEX 3002 (BD3002)

View all 14 devices →

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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.

↑