Product Code: HFW FDA class 2 21 CFR 884.4530

Clamp, Umbilical

Obstetrics/Gynecology

The Umbilical Clamp is a device used immediately after birth to clamp the umbilical cord, cutting off blood flow between the infant and the placenta before the cord is cut. It is classified as FDA Class 2 (moderate risk) within the Obstetrics/Gynecology specialty and is subject to general controls. The product code is HFW, regulated under 21 CFR 884.4530. No implant or life-sustaining flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HFW
Device Class: FDA class 2
Regulation Number: 884.4530
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K041332	JOEY CLAMP OPENING TOOL	Jun 25, 2004	Substantially Equivalent	Maternus, Inc.
K033846	KAEN YIH UMBILICAL CORD CLAMP	Mar 11, 2004	Substantially Equivalent	Kaen Yih Enterprise Co., Ltd.
K020718	SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE	Jun 03, 2002	Substantially Equivalent	Precision Dynamics Corp.
K021055	BUSSE UMBILICAL CORD CLAMP CUTTER	Apr 29, 2002	Substantially Equivalent	Busse Hospital Disposables, Inc.
K012917	DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B	Nov 28, 2001	Substantially Equivalent	Dynarex Corp.
K011621	KOALA CLAMP, KOALA CLAMP AND CUTTER	Aug 10, 2001	Substantially Equivalent	Maternus, Inc.
K010695	KOALA CLAMP	May 03, 2001	Substantially Equivalent	Maternus, Inc.
K010835	POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385	Apr 30, 2001	Substantially Equivalent	Busse Hospital Disposables, Inc.
K000227	UMBICUT	Apr 27, 2000	Substantially Equivalent	Pollak (Intl.), Ltd.
K994367	UMBILICAL CORD CLAMP	Mar 17, 2000	Substantially Equivalent	Medical Sales Co.
K994263	SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540	Jan 24, 2000	Substantially Equivalent	Precision Dynamics Corp.
K990737	'ECURLINE UMBILICAL CORD CLAMP #3500	Apr 06, 1999	Substantially Equivalent	Precision Dynamics Corp.
K983204	HARWILL MEDICAL U-KLIP UMBILICAL CLAMP	Feb 26, 1999	Substantially Equivalent	Harwill Medical (Pty) , Ltd.
K974227	HOSPITAL'S CLAMP	Dec 12, 1997	Substantially Equivalent	Gps
K963223	EZ-CIRC	Apr 23, 1997	Substantially Equivalent	Phyllis Adams, Rn, Npc, Msn
K963889	QFC UMBILICAL CLAMP	Apr 18, 1997	Substantially Equivalent	Qfc Industries
K963428	UMBILICAL CLAMP AND CUTTER	Apr 01, 1997	Substantially Equivalent	R.O.S.T. Medical Development, Inc.
K945841	BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP	May 30, 1995	Substantially Equivalent	W G M Corp.
K951140	KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR	May 25, 1995	Substantially Equivalent	Balagan Medical, Inc.
K933763	SAVE-T-BREATH AMBILICAL CORD CLAMP	Aug 29, 1994	Substantially Equivalent	Save-T-Breath Distributors C.C.
K934525	AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER	Feb 14, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K923439	LUNEAU UMBILICAL CORD CLAMP	May 21, 1993	Substantially Equivalent	Laboratoires Luneau
K912419	CORDGUARD BLOOD COLLECTION DEVICE	Oct 05, 1992	Substantially Equivalent	O.B. Tech., Inc.
K915569	UMBILICAL CLAMP	Sep 23, 1992	Substantially Equivalent	Gam Industries, Inc.
K912054	LABOR DELIVERY TRAY	Jan 21, 1992	Unknown	Medical Device Inspection Co., Inc.
K912869	WOMEN AND INFANT'S DELIVERY PACK	Dec 04, 1991	Substantially Equivalent	Welcon, Inc.
K901954	AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC	Jul 26, 1990	Substantially Equivalent	Hollister, Inc.
K901557	UMBILICAL CORD CLAMP AND CUTTER	May 15, 1990	Substantially Equivalent	Microtek-Heritage, Inc.
K894646	#556 DISPOSABLE UMBILICAL CORD CLAMP (2)	Sep 05, 1989	Substantially Equivalent	Alpha Unlimited, Inc.
K890382	COMPRESSION FORCEPS	Feb 27, 1989	Substantially Equivalent	Kinetic Medical Products
K880753	UMBILICAL CORD CLAMP	Apr 27, 1988	Substantially Equivalent	I M, Inc.
K871075	SCMT UMBILICAL CLAMP	Mar 23, 1987	Substantially Equivalent	Salt Creek Medical Technologies
K870446	DOLPHIN UMBILICAL CORD CLAMP	Feb 17, 1987	Substantially Equivalent	Andermac, Inc.
K863645	SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000	Sep 25, 1986	Substantially Equivalent	United Medical Systems, Inc.
K860445	CLAMP-N-CUT	Apr 04, 1986	Substantially Equivalent	Mmi, Inc.
K781548	UMBILICAL CORD CLAMP	Oct 17, 1978	Substantially Equivalent	Hollister, Inc.