RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40— 510(k) K101657

Name: FDA 510(k) clearance K101657
Creator: U.S. Food and Drug Administration
Published: 2010-10-05

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K101657 for RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40, Substantially Equivalent on 2010-10-05. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code KGE
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2010-06-11
Decision date: 2010-10-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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