510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823118Substantially Equivalent

Say

Kells Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823118 is the FDA 510(k) clearance record for SAY, a class I device, cleared for Kells Medical, Inc. on under FDA product code ESE (Larynx, Artificial (Battery-Powered)). FDA records list 12 510(k) clearances for Kells Medical, Inc., from to . As of , FDA records show no recalls naming K823118.

Clearance record

Decision date
Received
(78 days to decision)
Product code
ESE Larynx, Artificial (Battery-Powered)
Regulation
21 CFR 874.3375
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Kells Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ESE

Trailing 12 months

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

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