Definition: This Product Code Is The Class II Exempt Counterpart Of KKX, 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 | 5878 |
| Device Name | Drape, Surgical, Exempt |
| Physical State | Exemption Is Limited To Surgical Drapes That Do Not Include An Antimicrobial Agent. |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of KKX, 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 KKX, 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 | Surgical Drape And Drape Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PUI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5878 |
| Device | Drape, Surgical, Exempt |
| Product Code | PUI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Drape And Drape Accessories. |
| CFR Regulation Number | 878.4370 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
Device Contamination With Biological Material | 2 |
Microbial Contamination Of Device | 1 |
Contamination / Decontamination Problem | 1 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ecolab Inc | II | Oct-24-2018 |