510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963839Substantially Equivalent

Cordis Suction Reservoir - Model Number: 910-500

Cordis US Corp., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963839 is the FDA 510(k) clearance record for CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500, a class I device, cleared for Cordis Corp. on under FDA product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K963839.

Clearance record

Decision date
Received
(79 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
Cordis Corp. 14201 NW 60th Ave., Miami Lakes FL
510(k) summary
Summary
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