510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915359Substantially Equivalent

Promeon Hydrogel Dressing #45 Sterile W/ Mesh

Medtronic, Inc., Brooklyn Center MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915359 is the FDA 510(k) clearance record for PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH, a class I device, cleared for Medtronic Vascular on under FDA product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K915359.

Clearance record

Decision date
Received
(183 days to decision)
Product code
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Regulation
21 CFR 878.4022
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medtronic Vascular 6700 Shingle Creek Pky, Brooklyn Center MN
510(k) summary
Summary
Third party review
No

Clearances, product code NAE

Trailing 12 months

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

FDA records show no clearances under product code NAE in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAE, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260