SPYSCOPE ACCESS AND DELIVERY CATHETER— 510(k) K090170

Name: FDA 510(k) clearance K090170
Creator: U.S. Food and Drug Administration
Published: 2009-02-04

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K090170 for SPYSCOPE ACCESS AND DELIVERY CATHETER, Substantially Equivalent on 2009-02-04. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code ODF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-01-23
Decision date: 2009-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODF

view all

K092739 — MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE2010-01-12
K091962 — POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-2002009-09-30
K052194 — SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR2005-08-24
K050403 — SPYGLASS DIRECT VISULATION PROBE2005-03-04
K963354 — 5 STAR MEDICAL ENDOSCOPE1997-09-08

More clearances from Boston Scientific Corp

view all

K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more2024-10-18
K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)2023-08-19
K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary2015-11-20
K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System2015-08-05
K150303 — XXL Vascular Balloon Dilatation Catheter2015-06-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.