Medicon Mogen Clamp
by Medicon EG
510(k) K100916
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100916 | Date6 Dec 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HFX
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Medicon Mogen Clamp is a surgical instrument classified as a Clamp, Circumcision, designed for use in male infant or child circumcision procedures. It is engineered to compress and secure the foreskin of the penis during the procedure, ensuring controlled application of force while minimising tissue trauma. Constructed from stainless steel, the device features a locking mechanism to prevent accidental release and chamfered edges to enhance safety during handling.
The clamp is manually operated by a surgeon in clinical settings such as hospitals or surgical clinics. It is intended for reusable use and requires proper sterilisation between procedures. The device adheres to FDA regulatory standards, having received FDA 510(k) clearance under the Obstetrics/Gynecology advisory committee classification (K100916). No additional regulatory markings or sterility claims are specified beyond its reusable design and stainless steel construction.