Definition: This Product Code Is The Class II Exempt Counterpart Of GAQ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k))
| Device Type ID | 5877 |
| Device Name | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt |
| Physical State | Exemption Is Limited To Steel Monofilament Sutures That Are Uncoated And Do Not Incorporate Barbs. |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of GAQ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Target Area | This Product Code Is The Class II Exempt Counterpart Of GAQ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Regulation Description | Stainless Steel Suture. |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4495 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5877 |
| Device | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt |
| Product Code | PTX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stainless Steel Suture. |
| CFR Regulation Number | 878.4495 [🔎] |