510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821177Substantially Equivalent

Bite Stick

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

K821177 is the FDA 510(k) clearance record for BITE STICK, a class I device, cleared for Abco Dealers, Inc. on under FDA product code FMA (Depressor, Tongue, Non-Surgical). FDA records list 127 510(k) clearances for Abco Dealers, Inc., from to . As of , FDA records show no recalls naming K821177.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FMA Depressor, Tongue, Non-Surgical
Regulation
21 CFR 880.6230
Device class
Class I
Review panel
General Hospital
Applicant
Abco Dealers, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FMA

Trailing 12 months

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

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