Cleared Traditional

K011402 - BIOPSY SITE MARKER (FDA 510(k) Clearance)

K011402 · Senorx, Inc. · General & Plastic Surgery device

Jul 2001

Decision

70d

Days

Class 2

Risk

K011402 is an FDA 510(k) clearance for the BIOPSY SITE MARKER. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on July 16, 2001, 70 days after receiving the submission on May 7, 2001.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number	K011402 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 07, 2001
Decision Date	July 16, 2001
Days to Decision	70 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF