510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K942205Substantially Equivalent

Zebra Urological Guidewire

Boston Scientific Corporation, Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942205 is the FDA 510(k) clearance record for ZEBRA UROLOGICAL GUIDEWIRE, a class II device, cleared for Boston Scientific Corp on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K942205.

Clearance record

Decision date
Received
(63 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp 480 Pleasant St., Watertown MA
510(k) summary
Summary
Third party review
No

Clearances, product code KNY

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