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)

NEEDLE, CHIBA UNIVERSITY

K-Number: K771108 · 1977-07-29

ApplicantJohannah Medical Services, Inc.
Decision Date1977-07-29
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEEDLE, CHIBA UNIVERSITY is the device name listed in this FDA 510(k) record. The listed applicant is Johannah Medical Services, Inc.. It received FDA 510(k) clearance on 1977-07-29 under 510(k) number K771108. 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 NEEDLE, CHIBA UNIVERSITY?

NEEDLE, CHIBA UNIVERSITY is a medical device that received FDA 510(k) clearance on 1977-07-29. The listed applicant is Johannah Medical Services, Inc.. The 510(k) number is K771108.

When did NEEDLE, CHIBA UNIVERSITY receive FDA 510(k) clearance?

NEEDLE, CHIBA UNIVERSITY received FDA 510(k) clearance on 1977-07-29, under 510(k) number K771108.

Who is the listed applicant for NEEDLE, CHIBA UNIVERSITY?

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

What is the FDA product code for NEEDLE, CHIBA UNIVERSITY?

The FDA product code for NEEDLE, CHIBA UNIVERSITY 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 Johannah Medical Services, 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.

K801304CAMLOC SYRINGE BIOPSY KITK791643BONE MARROW NEEDLEK770370CONVENIENCE TRAY

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.

↑