FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Konig Mogen Clamp
K Number: K212911
·
Decision Nov 18, 2022
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
238
Review Days
431
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Konig Mogen Clamp
- K Number
- K212911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline Industries, Inc.
- Date Received
- September 13, 2021
- Decision Date
- November 18, 2022
- Product Code
- HFX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HFX | Clamp, Circumcision | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFX), ordered by most recent decision date.
Konig Bell Circumcision Clamp
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Wee Bell
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Circumplast Circumcision Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MALE CIRCUMCISION KITS:RAPIDECLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SHANGRING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SHANGRING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Medline Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN210049 | Medline ART Skin Harvesting System | Mar 27, 2024 | Unknown |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Oct 26, 2023 | Substantially Equivalent |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Jun 27, 2023 | Substantially Equivalent |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Jan 25, 2023 | Substantially Equivalent |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Dec 9, 2022 | Substantially Equivalent |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Oct 25, 2022 | Substantially Equivalent |
| K213481 | Medline General Surgery Tray | May 24, 2022 | Substantially Equivalent |
| K212093 | Medline Universal Grounding Pad | Jan 14, 2022 | Substantially Equivalent |
| K213068 | Medline Smoke Evacuation Shroud | Jan 3, 2022 | Substantially Equivalent |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Dec 10, 2021 | Substantially Equivalent |