510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800227Substantially Equivalent

Ml-800 CO2

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

K800227 is the FDA 510(k) clearance record for ML-800 CO2, a class II device, cleared for Merrimack Laboratories on under FDA product code HHR (Laser, Surgical, Gynecologic). FDA records list 6 510(k) clearances for Merrimack Laboratories, from to . As of , FDA records show no recalls naming K800227.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HHR Laser, Surgical, Gynecologic
Regulation
21 CFR 884.4550
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Merrimack Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HHR

Trailing 12 months

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

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