510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K023025Substantially Equivalent

Self Seal Sterilization Pouch

Granton Medical, Ltd., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023025 is the FDA 510(k) clearance record for SELF SEAL STERILIZATION POUCH, a class II device, cleared for Granton Medical , Ltd. on under FDA product code FRG (Wrap, Sterilization). FDA records list 2 510(k) clearances for Granton Medical , Ltd., from to . As of , FDA records show no recalls naming K023025.

Clearance record

Decision date
Received
(174 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Granton Medical , Ltd. P.O. Box 4341, Crofton MD
510(k) summary
Statement
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260