510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984345Substantially Equivalent

Aromapatch

Envis, Inc., Asheville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984345 is the FDA 510(k) clearance record for AROMAPATCH, a class I device, cleared for Envis, Inc. on under FDA product code LRD (Applicator, Ent Drug). FDA records list one 510(k) clearance for Envis, Inc. As of , FDA records show no recalls naming K984345.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LRD Applicator, Ent Drug
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Envis, Inc. 25 Hertiage Dr., Asheville NC
510(k) summary
Statement
Third party review
No

Clearances, product code LRD

Trailing 12 months

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

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