FDA.reportPublic FDA data

510(k) K172800

Device
Portex® Lancet Point Spinal Needles With NRFit™ Connectors, Portex® Pencil Point Spinal Needles With NRFit™ Connectors
Applicant
Smiths Medical ASD, Inc.
510(k) number
K172800
Product code
MIA  
Decision
Substantially Equivalent (SESE)
Decision date
2018-06-14
Date received
2017-09-18
Regulation
868.5150
Classification name
Needle, Spinal, Short Term
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michael R. Johnson
Address
6000 Nathan Ln. N Plymouth MN US 55442 55442

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MIA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837Epimed International, Inc.2005-08-22
K983858SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLESSims Portex, Inc.1999-01-29
K982269CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GAAllegiance Healthcare Corp.1998-07-23
K971645REGANES SPINAL NEEDLE (VARIOUS)Avid N.I.T., Inc.1997-08-01
K970997NEO-CARE LUMBER PUNCTURE KITKlein-Baker Medical, Inc.1997-05-22
K961324GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLESGlobal Medical Prods, Inc.1996-07-02
K960405SPINAL NEEDLEPromex, Inc.1996-02-28
K942442ACUFEX T-FIX DELIVERY SYSTEMAcufex Microsurgical, Inc.1994-12-05
K904380SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEMCustom Medical Concepts, Inc.1993-04-08

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases