510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K202566Substantially Equivalent

Wiygul Catheter

Big Blue Biotech, Inc., Canton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202566 is the FDA 510(k) clearance record for Wiygul Catheter, a class II device, cleared for Big Blue Biotech, Inc. on under FDA product code EZD (Catheter, Straight). FDA records list one 510(k) clearance for Big Blue Biotech, Inc. As of , FDA records show no recalls naming K202566.

Clearance record

Decision date
Received
(26 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Big Blue Biotech, Inc. 690 Canton St., Suite 302, Canton MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code EZD

Trailing 12 months
11 clearances under product code EZD in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20261
April 20262
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260