510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833061Substantially Equivalent

C-Flex Penrose Drainage Tube

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

K833061 is the FDA 510(k) clearance record for C-FLEX PENROSE DRAINAGE TUBE, a class II device, cleared for Concept, Inc. on under FDA product code FFA (Tube, Drainage, Suprapubic). FDA records list 83 510(k) clearances for Concept, Inc., from to . As of , FDA records show no recalls naming K833061.

Clearance record

Decision date
Received
(59 days to decision)
Product code
FFA Tube, Drainage, Suprapubic
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Concept, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FFA

Trailing 12 months

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

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