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)

INTRACAVITY NEEDLE GUIDE KIT

K-Number: K955668 · 1997-07-30

ApplicantArlanda Medicinska Instrument Co. AB
Decision Date1997-07-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRACAVITY NEEDLE GUIDE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Arlanda Medicinska Instrument Co. AB. It received FDA 510(k) clearance on 1997-07-30 under 510(k) number K955668. 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 INTRACAVITY NEEDLE GUIDE KIT?

INTRACAVITY NEEDLE GUIDE KIT is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Arlanda Medicinska Instrument Co. AB. The 510(k) number is K955668.

When did INTRACAVITY NEEDLE GUIDE KIT receive FDA 510(k) clearance?

INTRACAVITY NEEDLE GUIDE KIT received FDA 510(k) clearance on 1997-07-30, under 510(k) number K955668.

Who is the listed applicant for INTRACAVITY NEEDLE GUIDE KIT?

The FDA 510(k) record lists Arlanda Medicinska Instrument Co. AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRACAVITY NEEDLE GUIDE KIT?

The FDA product code for INTRACAVITY NEEDLE GUIDE KIT 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

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.

↑