Kordklamp Umbilical Cord Clamp Applicator

FDA 510(k) K951140 · Balagan Medical, Inc.

Substantially Equivalent

510(k) numberK951140

Submission

Device name
Kordklamp Umbilical Cord Clamp Applicator
Applicant
Balagan Medical, Inc.
Huntington Beach, CA, US
Received
March 13, 1995
Decision date
May 25, 1995
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
K011621Koala Clamp, Koala Clamp and CutterHFW · Traditional Maternus, Inc.08/10/2001SE
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

Questions and answers

When was Kordklamp Umbilical Cord Clamp Applicator cleared by the FDA?

Kordklamp Umbilical Cord Clamp Applicator (K951140) received a 510(k) decision of Substantially Equivalent on May 25, 1995, 73 days after the submission was received.

What is the product code of K951140?

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