510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833586Substantially Equivalent

Tls Bulb Drainage System

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

K833586 is the FDA 510(k) clearance record for TLS BULB DRAINAGE SYSTEM, a class I device, cleared for Porex Medical on under FDA product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered). FDA records list 15 510(k) clearances for Porex Medical, from to . As of , FDA records show 2 recalls naming K833586.

Clearance record

Decision date
Received
(110 days to decision)
Product code
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Regulation
21 CFR 878.4680
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Porex Medical 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GCY

Trailing 12 months

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

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