510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771615Substantially Equivalent

Audi-Sil Earmold Material

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

K771615 is the FDA 510(k) clearance record for AUDI-SIL EARMOLD MATERIAL, a class II device, cleared for Coe Laboratories, Inc. on under FDA product code ESH (Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane). FDA records list 20 510(k) clearances for Coe Laboratories, Inc., from to . As of , FDA records show no recalls naming K771615.

Clearance record

Decision date
Received
(6 days to decision)
Product code
ESH Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Coe Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ESH

Trailing 12 months

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

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