| Device Type ID | 3939 |
| Device Name | Clamp, Circumcision |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.4530 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HFX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3939 |
| Device | Clamp, Circumcision |
| Product Code | HFX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDICFIT TECHNOLOGY SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVADIEN HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Handling Problem | 103 |
Use Of Device Problem | 22 |
Improper Or Incorrect Procedure Or Method | 17 |
Device Operates Differently Than Expected | 17 |
Device Issue | 3 |
Device Contamination With Biological Material | 3 |
Insufficient Information | 2 |
Device Misassembled During Manufacturing / Shipping | 1 |
Incorrect Device Or Component Shipped | 1 |
Failure To Obtain Sample | 1 |
Human Factors Issue | 1 |
Clamp | 1 |
Defective Component | 1 |
No Apparent Adverse Event | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 175 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap Implant Systems LLC | II | Jan-05-2017 |
| 2 | DeRoyal Industries Inc | II | Mar-04-2014 |
| 3 | Instrumed International, Inc. | II | Dec-16-2014 |