510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K944854Substantially Equivalent

Sterisure Sterilization Wrap

Fiberweb North America, Inc., Simpsonville SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944854 is the FDA 510(k) clearance record for STERISURE STERILIZATION WRAP, a class II device, cleared for Fiberweb North America, Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list one 510(k) clearance for Fiberweb North America, Inc. As of , FDA records show no recalls naming K944854.

Clearance record

Decision date
Received
(80 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Fiberweb North America, Inc. 840 S. E. Main St., Simpsonville SC
510(k) summary
Summary
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