510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821162Substantially Equivalent

Adhesive Remover

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

K821162 is the FDA 510(k) clearance record for ADHESIVE REMOVER, a class I device, cleared for The Healthcare Group Laboratories, Inc. on under FDA product code KOX (Solvent, Adhesive Tape). FDA records list 29 510(k) clearances for The Healthcare Group Laboratories, Inc., from to . As of , FDA records show no recalls naming K821162.

Clearance record

Decision date
Received
(18 days to decision)
Product code
KOX Solvent, Adhesive Tape
Regulation
21 CFR 878.4730
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
The Healthcare Group Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KOX

Trailing 12 months

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

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