510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942315Substantially Equivalent

Navarre Percutaneous Access Set

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

K942315 is the FDA 510(k) clearance record for NAVARRE PERCUTANEOUS ACCESS SET, a class I device, cleared for Navarre Biomedical , Ltd. on under FDA product code KGZ (Accessories, Catheter). FDA records list 9 510(k) clearances for Navarre Biomedical , Ltd., from to . As of , FDA records show no recalls naming K942315.

Clearance record

Decision date
Received
(56 days to decision)
Product code
KGZ Accessories, Catheter
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Navarre Biomedical , Ltd. 705 Tower Dr., Hamel MN
510(k) summary
Summary
Third party review
No

Clearances, product code KGZ

Trailing 12 months

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

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