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)

BRAUN PREFILLED SYRINGE

K-Number: K970736 · 1998-12-16

ApplicantB.Braun Medical, Inc.
Decision Date1998-12-16
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BRAUN PREFILLED SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K970736. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAUN PREFILLED SYRINGE?

BRAUN PREFILLED SYRINGE is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K970736.

When did BRAUN PREFILLED SYRINGE receive FDA 510(k) clearance?

BRAUN PREFILLED SYRINGE received FDA 510(k) clearance on 1998-12-16, under 510(k) number K970736.

Who is the listed applicant for BRAUN PREFILLED SYRINGE?

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

What is the FDA product code for BRAUN PREFILLED SYRINGE?

The FDA product code for BRAUN PREFILLED SYRINGE is FOZ.

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 B.Braun Medical, 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.

K254111Irrigation/Urology SetsK253235Introcan Safety® Deep Access XL IV CatheterK243392Infusomat® Space Volumetric Infusion Pump Administration SetsK240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemK241845Introcan Safety® 2 IV CatheterK241385Omnifix Syringe NRFit

View all 142 devices →

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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.

↑