MODIFICATION TO T-REX BIOPSY FORCEPS— 510(k) K000409

Name: FDA 510(k) clearance K000409
Creator: U.S. Food and Drug Administration
Published: 2000-02-28

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K000409 for MODIFICATION TO T-REX BIOPSY FORCEPS, Substantially Equivalent on 2000-02-28. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code DWZ
Device class: Class 2
Regulation: 21 CFR 870.4075
Advisory panel: Cardiovascular
Date received: 2000-02-08
Decision date: 2000-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWZ

view all

K252722 — Biopsy Forceps2025-09-30
K170726 — Biopsy Forceps2017-06-02
K072051 — NOVATOME, MODEL: SU101-502007-10-03
K010473 — SPARROWHAWK DISPOSABLE2001-06-06
K991486 — ULTRA-CBX1999-11-05

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.