510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K913636Substantially Equivalent

Orbis-Sigma Valve System for Ventricular Shunting

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

K913636 is the FDA 510(k) clearance record for ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING, a class II device, cleared for Cordis Corp. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K913636.

Clearance record

Decision date
Received
(119 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Cordis Corp. 14201 NW 60th Ave., Miami Lakes FL
510(k) summary
Statement
Third party review
No

Clearances, product code JXG

Trailing 12 months
3 clearances under product code JXG in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261
November 20260