510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943663Substantially Equivalent

Navarre 600 Ml Drainage Bag

Navarre Biomedical, Ltd., Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943663 is the FDA 510(k) clearance record for NAVARRE 600 ML DRAINAGE BAG, a class II device, cleared for Navarre Biomedical , Ltd. on under FDA product code EXF (Bag, Bile Collecting). FDA records list 9 510(k) clearances for Navarre Biomedical , Ltd., from to . As of , FDA records show no recalls naming K943663.

Clearance record

Decision date
Received
(42 days to decision)
Product code
EXF Bag, Bile Collecting
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Navarre Biomedical , Ltd. 2545 Fernbrook Ln. N., Plymouth MN
510(k) summary
Summary
Third party review
No

Clearances, product code EXF

Trailing 12 months

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

FDA records show no clearances under product code EXF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EXF, 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