Centurion Circlamp
FDA 510(k) K890897 · Tri-State Hospital Supply Corp.
510(k) numberK890897
Submission
- Device name
- Centurion Circlamp
- Applicant
- Tri-State Hospital Supply Corp.
Howell, MI, US - Received
- February 22, 1989
- Decision date
- March 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFX – Clamp, Circumcision
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251687 | Konig Bell Circumcision ClampHFX · Traditional | Medline Industries, LP | 02/25/2026SE |
| K221356 | Wee BellHFX · Traditional | Wee Medical | 02/02/2023SE |
| K212911 | Konig Mogen ClampHFX · Traditional | Medline Industries, Inc. | 11/18/2022SE |
| K151095 | Circumplast Circumcision DeviceHFX · Traditional | Novadien Healthcare | 09/18/2015SE |
| K142163 | Male Circumcision Kits:RapideclampHFX · Traditional | Medicfit Technology Sdn Bhd | 04/20/2015SE |
| K131373 | ShangringHFX · Special | Wuhu Snnda Medical Treatment Appliance Technology | 06/25/2013SE |
| K121789 | ShangringHFX · Traditional | Wuhu Snna Medical Treatment Appliance Technology C | 08/03/2012SE |
| K103695 | Prepex SystemHFX · Traditional | Circ Medtech | 01/10/2012SE |
| K100916 | Medicon Mogen ClampHFX · Traditional | Medicon EG | 12/06/2010SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | Clinical Innovations, LLC | 09/20/2007SE |
More from Clinical Innovations, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K080448 | Centurion Protective Restraint, SCR SeriesFMQ · Traditional | 08/28/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | 04/23/2008SE |
| K942353 | Centurion Umbilical CatheterFOS · Traditional | 08/15/1995SE |
| K945977 | Centurion(R) Site Guard(R) Transparent Dressing/Transpaent Film DressingMGP · Traditional | 03/29/1995SE |
| K931748 | Centlurion Disp Steri Dental/Hygiene Pack/TraysLJT · Traditional | 02/25/1994SESK |
| K935491 | Centurion Mogen Clamp/Circumcision (Ster/Non Ster)HFX · Traditional | 02/17/1994SE |
| K923812 | Centurion Disposable InstrumentsMDM · Traditional | 12/17/1992SE |
| K910906 | Centurion Kleen-Needle System I.V. Extension SetsFPK · Traditional | 04/01/1991SE |
| K897100 | Centurion Vaginal SpeculumHIC · Traditional | 03/16/1990SE |
| K896320 | Centurion Kleen-Needle SystemFMI · Traditional | 01/11/1990SE |
Questions and answers
When was Centurion Circlamp cleared by the FDA?
Centurion Circlamp (K890897) received a 510(k) decision of Substantially Equivalent on March 28, 1989, 34 days after the submission was received.
What is the product code of K890897?
The FDA product code is HFX – Clamp, Circumcision, a Class II (moderate risk) device regulated under 21 CFR 884.4530.