| Device Type ID | 5683 |
| Device Name | Clamp |
| Regulation Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HXD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5683 |
| Device | Clamp |
| Product Code | HXD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 102 |
Break | 91 |
Device-Device Incompatibility | 20 |
Mechanical Jam | 17 |
Component Missing | 13 |
Fracture | 12 |
Mechanical Problem | 10 |
Connection Problem | 8 |
Naturally Worn | 7 |
Loose Or Intermittent Connection | 6 |
Disassembly | 6 |
Fitting Problem | 5 |
Device Issue | 4 |
Device Operates Differently Than Expected | 4 |
Difficult To Remove | 3 |
Bent | 3 |
Product Quality Problem | 3 |
Separation Problem | 3 |
Crack | 3 |
Defective Device | 3 |
Insufficient Information | 2 |
Dull, Blunt | 2 |
Entrapment Of Device | 2 |
Difficult To Insert | 2 |
Physical Resistance / Sticking | 2 |
Material Twisted / Bent | 2 |
Difficult To Open Or Close | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Failure To Calibrate | 1 |
Defective Component | 1 |
Material Integrity Problem | 1 |
Incomplete Or Inadequate Connection | 1 |
Unintended Movement | 1 |
Locking Mechanism | 1 |
Clamp | 1 |
Material Fragmentation | 1 |
Material Separation | 1 |
Device Markings / Labelling Problem | 1 |
Material Distortion | 1 |
Positioning Problem | 1 |
Blocked Connection | 1 |
Failure To Discharge | 1 |
Difficult To Position | 1 |
Device Slipped | 1 |
Failure To Align | 1 |
| Total Device Problems | 356 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker GmbH | II | Jun-15-2018 |
| 2 | Symmetry Surgical, Inc. | II | Jul-30-2015 |