510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980997Substantially Equivalent

Pgk Device (Modified)

Pgk, Inc., Vienna VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980997 is the FDA 510(k) clearance record for PGK DEVICE (MODIFIED), a class I device, cleared for Pgk, Inc. on under FDA product code IWJ (System, Applicator, Radionuclide, Manual). FDA records list one 510(k) clearance for Pgk, Inc. As of , FDA records show no recalls naming K980997.

Clearance record

Decision date
Received
(195 days to decision)
Product code
IWJ System, Applicator, Radionuclide, Manual
Regulation
21 CFR 892.5650
Device class
Class I
Review panel
Radiology
Applicant
Pgk, Inc. 8320 Old Ct.house Rd., Vienna VA
510(k) summary
Summary
Third party review
No

Clearances, product code IWJ

Trailing 12 months

FDA records hold no clearances under product code IWJ in the trailing twelve months.

FDA records show no clearances under product code IWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260