510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K930348Substantially Equivalent

Combo Cath Wire-Guided Cytology System

Boston Scientific Corporation, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930348 is the FDA 510(k) clearance record for COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM, a class II device, cleared for Boston Scientific Corp on under FDA product code FDX (Endoscopic Cytology Brush). FDA's definition for product code FDX reads: "To collect cells for cytological evaluation". FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K930348.

Clearance record

Decision date
Received
(221 days to decision)
Product code
FDX Endoscopic Cytology Brush
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp 2710 Orchard Pkwy., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code FDX

Trailing 12 months
1 clearance under product code FDX 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 FDX, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260