FDA 510(k)

B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE

K-Number: K970737 · 1997-03-28

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1997-03-28

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K970737. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE?

B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K970737.

When did B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE receive FDA 510(k) clearance?

B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE received FDA 510(k) clearance on 1997-03-28, under 510(k) number K970737.

Who is the listed applicant for B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE?

The FDA product code for B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE is FMI.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

K003062BACTEC MGIT 960 SIR KITS K0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE K003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE K002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 K001364BD DIRECTIGEN FLU A+B K000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 devices →

Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., 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.