Cleared Traditional

NOVATOME, MODEL: SU101-50

K072051 · Scholten Surgical Instruments, Inc. · Cardiovascular
Oct 2007
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K072051 is an FDA 510(k) clearance for the NOVATOME, MODEL: SU101-50, a Device, Biopsy, Endomyocardial (Class II — Special Controls, product code DWZ), submitted by Scholten Surgical Instruments, Inc. (Lodi, US). The FDA issued a Cleared decision on October 3, 2007, 69 days after receiving the submission on July 26, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4075.

Submission Details

510(k) Number K072051 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2007
Decision Date October 03, 2007
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWZ — Device, Biopsy, Endomyocardial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4075