Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device
FDA 510(k) K061539 · Clinical Innovations, LLC
510(k) numberK061539
Submission
- Device name
- Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device
- Applicant
- Clinical Innovations, LLC
Murray, UT, US - Received
- June 5, 2006
- Decision date
- September 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K063429 | GMD Universal Circumcision Clamp, Model 200HFX · Traditional | Generic Medical Device, Inc. | 01/17/2007SE |
More from Generic Medical Device, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional | 10/08/2025SE |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E)HFN · Traditional | 05/22/2025SE |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP)FMK · Traditional | 02/24/2023SE |
| K153591 | ebb Complete Tamponade SystemOQY · Special | 01/14/2016SE |
| K150573 | ebb Complete Tamponade SystemOQY · Special | 03/25/2015SE |
| K140163 | Koala TocoHFM · Traditional | 05/29/2014SE |
| K131781 | Clearview TotalLKF · Traditional | 05/28/2014SE |
| K110605 | Rom PlusNQM · Traditional | 11/23/2011SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | 09/17/2003SE |
| K022023 | Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional | 01/07/2003SE |
Questions and answers
When was Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device cleared by the FDA?
Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device (K061539) received a 510(k) decision of Substantially Equivalent on September 20, 2007, 472 days after the submission was received.
What is the product code of K061539?
The FDA product code is HFX – Clamp, Circumcision, a Class II (moderate risk) device regulated under 21 CFR 884.4530.