#556 Disposable Umbilical Cord Clamp (2)
FDA 510(k) K894646 · Alpha Unlimited, Inc.
510(k) numberK894646
Submission
- Device name
- #556 Disposable Umbilical Cord Clamp (2)
- Applicant
- Alpha Unlimited, Inc.
Clearwater, FL, US - Received
- July 24, 1989
- Decision date
- September 5, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | 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 |
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|---|---|---|
| K893429 | Alpha CondorINI · Traditional | 06/12/1989SE |
| K893428 | Alpha ShopperITI · Traditional | 06/12/1989SE |
| K893248 | Alpha MallardINI · Traditional | 05/26/1989SE |
| K853766 | Alpha Super KartINI · Traditional | 11/20/1985SE |
| K841921 | Alpha Plus 1ITI · Traditional | 05/23/1984SE |
| K841920 | Mac-Multi-Adjustable ChairIPL · Traditional | 05/23/1984SE |
| K841919 | Alpha Tri-KartINI · Traditional | 05/23/1984SE |
| K841912 | Alpha 4 X 4ITI · Traditional | 05/23/1984SE |
| K841911 | Alpha Push KartINM · Traditional | 05/23/1984SE |
Questions and answers
When was #556 Disposable Umbilical Cord Clamp (2) cleared by the FDA?
#556 Disposable Umbilical Cord Clamp (2) (K894646) received a 510(k) decision of Substantially Equivalent on September 5, 1989, 43 days after the submission was received.
What is the product code of K894646?
The FDA product code is HFW – Clamp, Umbilical, a Class II (moderate risk) device regulated under 21 CFR 884.4530.