PGK Device (Modified)

FDA 510(k) K980997 · Pgk, Inc.

Substantially Equivalent

510(k) numberK980997

Submission

Device name
PGK Device (Modified)
Applicant
Pgk, Inc.
Vienna, VA, US
Received
March 17, 1998
Decision date
September 28, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
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
K961377Manan Prostate Locking Introducer SetIWJ · Traditional Manan Medical Products, Inc.07/03/1996SE

Questions and answers

When was PGK Device (Modified) cleared by the FDA?

PGK Device (Modified) (K980997) received a 510(k) decision of Substantially Equivalent on September 28, 1998, 195 days after the submission was received.

What is the product code of K980997?

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