510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K821820Substantially Equivalent

Mcsc6ps Medical Components

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

K821820 is the FDA 510(k) clearance record for MCSC6PS MEDICAL COMPONENTS, cleared for Medical Components, Inc. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 72 510(k) clearances for Medical Components, Inc., from to . As of , FDA records show no recalls naming K821820.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Medical Components, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LFL

Trailing 12 months
1 clearance under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260