Wee Bell
FDA 510(k) K221356 · Wee Medical
510(k) numberK221356
Submission
- Device name
- Wee Bell
- Applicant
- Wee Medical
Knoxville, TN, US - Received
- May 10, 2022
- Decision date
- February 2, 2023
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251687 | Konig Bell Circumcision ClampHFX · Traditional | Medline Industries, LP | 02/25/2026SE |
| 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 |
| K063429 | GMD Universal Circumcision Clamp, Model 200HFX · Traditional | Generic Medical Device, Inc. | 01/17/2007SE |
Questions and answers
When was Wee Bell cleared by the FDA?
Wee Bell (K221356) received a 510(k) decision of Substantially Equivalent on February 2, 2023, 268 days after the submission was received.
What is the product code of K221356?
The FDA product code is HFX – Clamp, Circumcision, a Class II (moderate risk) device regulated under 21 CFR 884.4530.