510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821801Substantially Equivalent

Norsen Debrider

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

K821801 is the FDA 510(k) clearance record for NORSEN DEBRIDER, a class I device, cleared for Bel-Med, Inc. on under FDA product code GED (Brush, Dermabrasion, Manual). FDA records list 2 510(k) clearances for Bel-Med, Inc., from to . As of , FDA records show no recalls naming K821801.

Clearance record

Decision date
Received
(43 days to decision)
Product code
GED Brush, Dermabrasion, Manual
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Bel-Med, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GED

Trailing 12 months

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

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