510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832068Substantially Equivalent

Cody Sacculotomy Tack

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

K832068 is the FDA 510(k) clearance record for CODY SACCULOTOMY TACK, a class II device, cleared for Micromedics, Inc. on under FDA product code ESX (Tack, Sacculotomy (Cody Tack)). FDA records list 29 510(k) clearances for Micromedics, Inc., from to . As of , FDA records show no recalls naming K832068.

Clearance record

Decision date
Received
(114 days to decision)
Product code
ESX Tack, Sacculotomy (Cody Tack)
Regulation
21 CFR 874.3760
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Micromedics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ESX

Trailing 12 months

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

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