Umbilical Cord Clamp
FDA 510(k) K880753 · I M, Inc.
510(k) numberK880753
Submission
- Device name
- Umbilical Cord Clamp
- Applicant
- I M, Inc.
Fairfield, NJ, US - Received
- February 25, 1988
- Decision date
- April 27, 1988
- 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
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| 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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| K881363 | Syringe Prefilled with WaterKOD · Traditional | 06/23/1988SE |
| K872741 | NutripumpFRN · Traditional | 10/20/1987SE |
| K871495 | Bandages Catalog Number: 101 to 220NAD · Traditional | 05/08/1987SE |
| K863785 | Makler CatheterHDR · Traditional | 12/11/1986SE |
| K854155 | Sterile Saline SolutionKMJ · Traditional | 12/10/1985SE |
| K853287 | HuboutFPA · Traditional | 10/17/1985SE |
| K853288 | Feeding Units & TubesKNT · Traditional | 10/04/1985SE |
| K853286 | Staple Remover · Traditional | 08/21/1985SE |
Questions and answers
When was Umbilical Cord Clamp cleared by the FDA?
Umbilical Cord Clamp (K880753) received a 510(k) decision of Substantially Equivalent on April 27, 1988, 62 days after the submission was received.
What is the product code of K880753?
The FDA product code is HFW – Clamp, Umbilical, a Class II (moderate risk) device regulated under 21 CFR 884.4530.