510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080032Substantially Equivalent

Envoycem, Model 1640

Envoy Medical Corporation, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080032 is the FDA 510(k) clearance record for ENVOYCEM, MODEL 1640, a class II device, cleared for Envoy Medical Corporation on under FDA product code NEA (Cement, Ear, Nose And Throat). FDA records list one 510(k) clearance for Envoy Medical Corporation. As of , FDA records show no recalls naming K080032.

Clearance record

Decision date
Received
(52 days to decision)
Product code
NEA Cement, Ear, Nose And Throat
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Envoy Medical Corporation 5000 Township Pkwy., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEA

Trailing 12 months

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

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