510(k) K212911
K212911 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Konig Mogen Clamp". The FDA issued a decision of Substantially Equivalent on November 18, 2022. The device falls under product code HFX (Clamp, Circumcision), a Class II device regulated under 21 CFR 884.4530. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2022
- Date Received
- September 13, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Circumcision
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type