Koala Clamp, Koala Clamp and Cutter

FDA 510(k) K011621 · Maternus, Inc.

Substantially Equivalent

510(k) numberK011621

Submission

Device name
Koala Clamp, Koala Clamp and Cutter
Applicant
Maternus, Inc.
San Antonio, TX, US
Received
May 25, 2001
Decision date
August 10, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HFW – Clamp, Umbilical
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFW

510(k)DeviceApplicantDecision
K041332Joey Clamp Opening ToolHFW · Traditional Maternus, Inc.06/25/2004SE
K033846Kaen Yih Umbilical Cord ClampHFW · Traditional Kaen Yih Enterprise Co., Ltd.03/11/2004SE
K020718Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterileHFW · Traditional Precision Dynamics Corp.06/03/2002SE
K021055Busse Umbilical Cord Clamp CutterHFW · Traditional Busse Hospital Disposables, Inc.04/29/2002SE
K012917Dynarex Umbilical Cord Lamp, Models 6833 and 6833-BHFW · Traditional Dynarex Corp.11/28/2001SE
K010695Koala ClampHFW · Traditional Maternus, Inc.05/03/2001SE
K010835Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp…HFW · Traditional Busse Hospital Disposables, Inc.04/30/2001SE
K000227UmbicutHFW · Traditional Pollak (Intl.), Ltd.04/27/2000SE
K994367Umbilical Cord ClampHFW · Traditional Medical Sales Co.03/17/2000SE
K994263Securline Umbilical Cord Clamp Clipper #3540HFW · Traditional Precision Dynamics Corp.01/24/2000SE

More from Precision Dynamics Corp.

510(k)DeviceDecision
K041332Joey Clamp Opening ToolHFW · Traditional 06/25/2004SE
K010695Koala ClampHFW · Traditional 05/03/2001SE

Questions and answers

When was Koala Clamp, Koala Clamp and Cutter cleared by the FDA?

Koala Clamp, Koala Clamp and Cutter (K011621) received a 510(k) decision of Substantially Equivalent on August 10, 2001, 77 days after the submission was received.

What is the product code of K011621?

The FDA product code is HFW – Clamp, Umbilical, a Class II (moderate risk) device regulated under 21 CFR 884.4530.