Plastic-Guides

FDA 510(k) K901842 · M & K Co.

Substantially Equivalent

510(k) numberK901842

Submission

Device name
Plastic-Guides
Applicant
M & K Co.
Tucson, AZ, US
Received
April 24, 1990
Decision date
July 11, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IWJ – System, Applicator, Radionuclide, Manual
Device class
Class I (low risk)
Regulation
21 CFR 892.5650
Specialty
Radiology

Other 510(k)s with product code IWJ

510(k)DeviceApplicantDecision
K010166Imagyn Isosleeve / Isostar Needle SystemIWJ · Traditional Imagyn Medical Technologies, Inc.12/03/2001SE
K980997PGK Device (Modified)IWJ · Traditional Pgk, Inc.09/28/1998SE
K972554Reganes Radionuclide Seed MagazineIWJ · Traditional Avid N.I.T., Inc.02/17/1998SE
K973037N.I.T., Inc. Radionuclide Seed Applicator, Model SA-1000IWJ · Traditional Avid N.I.T., Inc.01/27/1998SE
K974118Worldwide Medical Technologies Seed Implant Needle SetIWJ · Traditional Worldwide Medical Technologies, LLC01/23/1998SE
K973786Northwest Radiation Therapy Products, Precision Stepper and GuideIWJ · Traditional Nw Radiation Therapy Products01/02/1998SE
K973638N.I.T., Inc. Needle Guiding TemplateIWJ · Traditional Avid N.I.T., Inc.12/23/1997SE
K973184Prostate Seeding NeedleIWJ · Traditional Promex, Inc.11/21/1997SE
K963743Manan Prostate Uni-LockIWJ · Traditional Manan Medical Products, Inc.12/06/1996SE
K951052Weeks ApplicatorIWJ · Traditional Duke University Medical Center08/22/1996SE

Questions and answers

When was Plastic-Guides cleared by the FDA?

Plastic-Guides (K901842) received a 510(k) decision of Substantially Equivalent on July 11, 1990, 78 days after the submission was received.

What is the product code of K901842?

The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.