Cleared Traditional

Biopsy Forceps

K170726 · Fehling Instruments GmbH & Co. KG · Cardiovascular
Jun 2017
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K170726 is an FDA 510(k) clearance for the Biopsy Forceps, a Device, Biopsy, Endomyocardial (Class II — Special Controls, product code DWZ), submitted by Fehling Instruments GmbH & Co. KG (Karlstein, DE). The FDA issued a Cleared decision on June 2, 2017, 85 days after receiving the submission on March 9, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4075.

Submission Details

510(k) Number K170726 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2017
Decision Date June 02, 2017
Days to Decision 85 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