Clamp, Umbilical
FDA product code HFW · Class II (moderate risk) · 21 CFR 884.4530 · Obstetrics/Gynecology
36510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Precision Dynamics Corp. 3
- Maternus, Inc. 3
- Busse Hospital Disposables, Inc. 2
- Hollister, Inc. 2
- Medical Device Inspection Co., Inc. 1
- R.O.S.T. Medical Development, Inc. 1
- W G M Corp. 1
- Save-T-Breath Distributors C.C. 1
- United States Surgical, A Division of Tyco Healthc 1
- Laboratoires Luneau 1
- O.B. Tech., Inc. 1
- Gam Industries, Inc. 1
- Kaen Yih Enterprise Co., Ltd. 1
- Microtek-Heritage, Inc. 1
- Alpha Unlimited, Inc. 1
- Kinetic Medical Products 1
- I M, Inc. 1
- Salt Creek Medical Technologies 1
- Andermac, Inc. 1
- United Medical Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041332 | Joey Clamp Opening ToolHFW · Traditional | Maternus, Inc. | 06/25/2004SE |
| K033846 | Kaen Yih Umbilical Cord ClampHFW · Traditional | Kaen Yih Enterprise Co., Ltd. | 03/11/2004SE |
| K020718 | Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterileHFW · Traditional | Precision Dynamics Corp. | 06/03/2002SE |
| K021055 | Busse Umbilical Cord Clamp CutterHFW · Traditional | Busse Hospital Disposables, Inc. | 04/29/2002SE |
| K012917 | Dynarex Umbilical Cord Lamp, Models 6833 and 6833-BHFW · Traditional | Dynarex Corp. | 11/28/2001SE |
| K011621 | Koala Clamp, Koala Clamp and CutterHFW · Traditional | Maternus, Inc. | 08/10/2001SE |
| K010695 | Koala ClampHFW · Traditional | Maternus, Inc. | 05/03/2001SE |
| K010835 | Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp…HFW · Traditional | Busse Hospital Disposables, Inc. | 04/30/2001SE |
| K000227 | UmbicutHFW · Traditional | Pollak (Intl.), Ltd. | 04/27/2000SE |
| K994367 | Umbilical Cord ClampHFW · Traditional | Medical Sales Co. | 03/17/2000SE |
| K994263 | Securline Umbilical Cord Clamp Clipper #3540HFW · Traditional | Precision Dynamics Corp. | 01/24/2000SE |
| K990737 | 'Ecurline Umbilical Cord Clamp #3500HFW · Traditional | Precision Dynamics Corp. | 04/06/1999SE |
| K983204 | Harwill Medical U-Klip Umbilical ClampHFW · Traditional | Harwill Medical (Pty) , Ltd. | 02/26/1999SE |
| K974227 | Hospital's ClampHFW · Traditional | Gps | 12/12/1997SE |
| K963223 | Ez-CircHFW · Traditional | Phyllis Adams, Rn, Npc, Msn | 04/23/1997SE |
| K963889 | QFC Umbilical ClampHFW · Traditional | Qfc Industries | 04/18/1997SE |
| K963428 | Umbilical Clamp and CutterHFW · Traditional | R.O.S.T. Medical Development, Inc. | 04/01/1997SE |
| K945841 | Birth Theft Infant Identification and Protection Umbilical Cord ClampHFW · Traditional | W G M Corp. | 05/30/1995SE |
| K951140 | Kordklamp Umbilical Cord Clamp ApplicatorHFW · Traditional | Balagan Medical, Inc. | 05/25/1995SE |
| K933763 | Save-T-Breath Ambilical Cord ClampHFW · Traditional | Save-T-Breath Distributors C.C. | 08/29/1994SE |
| K934525 | Auto Suture Disposable Umbilical Clip ApplierHFW · Traditional | United States Surgical, A Division of Tyco Healthc | 02/14/1994SE |
| K923439 | Luneau Umbilical Cord ClampHFW · Traditional | Laboratoires Luneau | 05/21/1993SE |
| K912419 | Cordguard Blood Collection DeviceHFW · Traditional | O.B. Tech., Inc. | 10/05/1992SE |
| K915569 | Umbilical ClampHFW · Traditional | Gam Industries, Inc. | 09/23/1992SE |
| K912054 | Labor Delivery TrayHFW · Traditional | Medical Device Inspection Co., Inc. | 01/21/1992SESK |
| K912869 | Women and Infant's Delivery PackHFW · Traditional | Welcon, Inc. | 12/04/1991SE |
| K901954 | Ameda/Egnell Dolphin Umbilical Cord Severing DevicHFW · Traditional | Hollister, Inc. | 07/26/1990SE |
| K901557 | Umbilical Cord Clamp and CutterHFW · Traditional | Microtek-Heritage, Inc. | 05/15/1990SE |
| K894646 | #556 Disposable Umbilical Cord Clamp (2)HFW · Traditional | Alpha Unlimited, Inc. | 09/05/1989SE |
| K890382 | Compression ForcepsHFW · Traditional | Kinetic Medical Products | 02/27/1989SE |
| K880753 | Umbilical Cord ClampHFW · Traditional | I M, Inc. | 04/27/1988SE |
| K871075 | SCMT Umbilical ClampHFW · Traditional | Salt Creek Medical Technologies | 03/23/1987SE |
| K870446 | Dolphin Umbilical Cord ClampHFW · Traditional | Andermac, Inc. | 02/17/1987SE |
| K863645 | Schulman Double Umbilical Cord Clamp No. 1000HFW · Traditional | United Medical Systems, Inc. | 09/25/1986SE |
| K860445 | Clamp-N-CutHFW · Traditional | Mmi, Inc. | 04/04/1986SE |
| K781548 | Umbilical Cord ClampHFW · Traditional | Hollister, Inc. | 10/17/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1273-2013 Class II | Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use…Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord… | Cypress Medical Products LLC | 04/15/2013Terminated |