510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820493Substantially Equivalent

Deep Convex Face Plate

Smith'S Ostomy Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820493 is the FDA 510(k) clearance record for DEEP CONVEX FACE PLATE, a class I device, cleared for Smith'S Ostomy Products, Inc. on under FDA product code EXB (Collector, Ostomy). FDA records list 2 510(k) clearances for Smith'S Ostomy Products, Inc., from to . As of , FDA records show no recalls naming K820493.

Clearance record

Decision date
Received
(15 days to decision)
Product code
EXB Collector, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Smith'S Ostomy Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EXB

Trailing 12 months

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

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