Cleared Traditional

K031938 - GEL MARK III BIOPSY SITE MARKER (FDA 510(k) Clearance)

K031938 · Senorx, Inc. · General & Plastic Surgery device

Sep 2003

Decision

74d

Days

Class 2

Risk

K031938 is an FDA 510(k) clearance for the GEL MARK III BIOPSY SITE MARKER. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 5, 2003, 74 days after receiving the submission on June 23, 2003.

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

Submission Details

510(k) Number	K031938 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 2003
Decision Date	September 05, 2003
Days to Decision	74 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF