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)

BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES

K-Number: K895725 · 1989-11-06

ApplicantInterson Corp.
Decision Date1989-11-06
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Interson Corp.. It received FDA 510(k) clearance on 1989-11-06 under 510(k) number K895725. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES?

BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES is a medical device that received FDA 510(k) clearance on 1989-11-06. The listed applicant is Interson Corp.. The 510(k) number is K895725.

When did BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES receive FDA 510(k) clearance?

BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES received FDA 510(k) clearance on 1989-11-06, under 510(k) number K895725.

Who is the listed applicant for BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES?

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

What is the FDA product code for BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES?

The FDA product code for BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES is FCG.

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 Interson Corp. 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.

K911116INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYSTK911115INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEMK911113INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYSTK911117INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYSTK911114INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEMK911464INTERSON DISPOSABLE BIOPSY NEEDLE

View all 9 devices →

Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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.

↑