510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113353Substantially Equivalent

Gemini Sterilzation Wrap

MEDLINE INDUSTRIES, LP - Northfield, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K113353 is the FDA 510(k) clearance record for GEMINI STERILZATION WRAP, a class II device, cleared for Medline Industries, Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K113353.

Clearance record

Decision date
Received
(444 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Medline Industries, Inc. One Medline Pl., Mundelein IL
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 November 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260