510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830354Substantially Equivalent

Colorectal Dilator

Cleveland Medical Supply & Services, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830354 is the FDA 510(k) clearance record for COLORECTAL DILATOR, a class I device, cleared for Cleveland Medical Supply & Services on under FDA product code FFP (Dilator, Rectal). FDA records list one 510(k) clearance for Cleveland Medical Supply & Services. As of , FDA records show no recalls naming K830354.

Clearance record

Decision date
Received
(113 days to decision)
Product code
FFP Dilator, Rectal
Regulation
21 CFR 876.5450
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Cleveland Medical Supply & Services 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FFP

Trailing 12 months

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

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