Ez-Circ
FDA 510(k) K963223 · Phyllis Adams, Rn, Npc, Msn
510(k) numberK963223
Submission
- Device name
- Ez-Circ
- Applicant
- Phyllis Adams, Rn, Npc, Msn
Marlton, NJ, US - Received
- August 16, 1996
- Decision date
- April 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
Questions and answers
When was Ez-Circ cleared by the FDA?
Ez-Circ (K963223) received a 510(k) decision of Substantially Equivalent on April 23, 1997, 250 days after the submission was received.
What is the product code of K963223?
The FDA product code is HFW – Clamp, Umbilical, a Class II (moderate risk) device regulated under 21 CFR 884.4530.