Cleared Traditional

K042503 - KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
(FDA 510(k) Clearance)

K042503 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat

Oct 2004

Decision

16d

Days

Class 2

Risk

K042503 is an FDA 510(k) clearance for the KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM. This device is classified as a Replacement, Ossicular Prosthesis, Total (Class II — Special Controls, product code ETA).

Submitted by Heinz Kurz GmbH Medizintechnik (Amsterdam, Nh, NL). The FDA issued a Cleared decision on October 1, 2004, 16 days after receiving the submission on September 15, 2004.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3495.

Submission Details

510(k) Number	K042503 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2004
Decision Date	October 01, 2004
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF