Cleared Traditional

K980997 - PGK DEVICE (MODIFIED)

K980997 is an FDA 510(k) clearance for PGK DEVICE (MODIFIED), manufactured by Pgk, Inc.. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K980997 · Pgk, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
195d
Days
Class 1
Risk

K980997 is an FDA 510(k) clearance for the PGK DEVICE (MODIFIED). Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Pgk, Inc. (Vienna, US). The FDA issued a Cleared decision on September 28, 1998 after a review of 195 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pgk, Inc. devices

FDA 510(k) Submission Details - K980997

510(k) Number K980997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1998
Decision Date September 28, 1998
Days to Decision 195 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 107d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

IWJ Device Classification - Class 1, General Controls

Product Code IWJ System, Applicator, Radionuclide, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5650
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IWJ System, Applicator, Radionuclide, Manual

All 22
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K980997.
REGANES RADIONUCLIDE SEED MAGAZINE
K972554 · Avid N.I.T., Inc. · Feb 1998
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
K973037 · Avid N.I.T., Inc. · Jan 1998
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
K974118 · Worldwide Medical Technologies, LLC · Jan 1998
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE
K973786 · Nw Radiation Therapy Products · Jan 1998
N.I.T., INC. NEEDLE GUIDING TEMPLATE
K973638 · Avid N.I.T., Inc. · Dec 1997
PROSTATE SEEDING NEEDLE
K973184 · Promex, Inc. · Nov 1997