510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001583Substantially Equivalent

Island Biosurgical Bns Kit #3

Island Biosurgical, Inc., Mercer Island WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001583 is the FDA 510(k) clearance record for ISLAND BIOSURGICAL BNS KIT #3, a class II device, cleared for Island Biosurgical, LLC on under FDA product code KOD (Catheter, Urological). FDA records list 4 510(k) clearances for Island Biosurgical, LLC, from to . As of , FDA records show no recalls naming K001583.

Clearance record

Decision date
Received
(52 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Island Biosurgical, LLC 18 Meadow Ln., Mercer Island WA
510(k) summary
Summary
Third party review
No

Clearances, product code KOD

Trailing 12 months
1 clearance under product code KOD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260