Cleared Traditional

K010695 - KOALA CLAMP
(FDA 510(k) Clearance)

K010695 · Maternus, Inc. · Obstetrics & Gynecology

May 2001

Decision

56d

Days

Class 2

Risk

K010695 is an FDA 510(k) clearance for the KOALA CLAMP. This device is classified as a Clamp, Umbilical (Class II — Special Controls, product code HFW).

Submitted by Maternus, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 3, 2001, 56 days after receiving the submission on March 8, 2001.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K010695 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2001
Decision Date	May 03, 2001
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF