Konig Bell Circumcision Clamp
FDA 510(k) K251687 · Medline Industries, LP
510(k) numberK251687
Submission
- Device name
- Konig Bell Circumcision Clamp
- Applicant
- Medline Industries, LP
Northfiled, IL, US - Received
- June 2, 2025
- Decision date
- February 25, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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 |
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| 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 |
| K063429 | GMD Universal Circumcision Clamp, Model 200HFX · Traditional | Generic Medical Device, Inc. | 01/17/2007SE |
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Questions and answers
When was Konig Bell Circumcision Clamp cleared by the FDA?
Konig Bell Circumcision Clamp (K251687) received a 510(k) decision of Substantially Equivalent on February 25, 2026, 268 days after the submission was received.
What is the product code of K251687?
The FDA product code is HFX – Clamp, Circumcision, a Class II (moderate risk) device regulated under 21 CFR 884.4530.