510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863560Substantially Equivalent

Uresil Std Flat/round & Flat/round Split. Sili/dra

Uresil, LLC, Skokie IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863560 is the FDA 510(k) clearance record for URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA, a class I device, cleared for Uresil Corp. on under FDA product code GBS (Catheter, Ventricular, General & Plastic Surgery). FDA records list 49 510(k) clearances for Uresil Corp., from to . As of , FDA records show no recalls naming K863560.

Clearance record

Decision date
Received
(17 days to decision)
Product code
GBS Catheter, Ventricular, General & Plastic Surgery
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Uresil Corp. 5418 W. Touhy Ave., Skokie IL
Third party review
No

Clearances, product code GBS

Trailing 12 months

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

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