| Device Type ID | 2825 |
| Device Name | Drape, Surgical |
| Regulation Description | Surgical Drape And Drape Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| 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) |
| CFR Regulation Number | 878.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KKX |
| 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 | 2825 |
| Device | Drape, Surgical |
| Product Code | KKX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Drape And Drape Accessories. |
| CFR Regulation Number | 878.4370 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ADVANCED VASCULAR DYNAMICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVALON TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FOSHAN NANHAI PLUS MEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GRIFFITH-LUCAS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WHITNEY MEDICAL SOLUTIONS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 10 |
Appropriate Term/Code Not Available | 9 |
Hole In Material | 6 |
Insufficient Information | 6 |
No Apparent Adverse Event | 5 |
Torn Material | 2 |
Break | 2 |
Material Rupture | 2 |
Thermal Decomposition Of Device | 1 |
Entrapment Of Device | 1 |
Flaked | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Material Opacification | 1 |
Out-Of-Box Failure | 1 |
Device Issue | 1 |
Device Packaging Compromised | 1 |
Sticking | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Loss Of Or Failure To Bond | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Failure To Adhere Or Bond | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Material Integrity Problem | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Fire | 1 |
| Total Device Problems | 60 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | May-30-2018 |
| 2 | Cardinal Health 200, LLC | II | Jul-07-2017 |
| 3 | Custom Medical Specialties, Inc. | II | Feb-12-2014 |
| 4 | Customed, Inc | II | Apr-14-2016 |
| 5 | Customed, Inc | II | Sep-03-2015 |
| 6 | Customed, Inc | I | Dec-16-2014 |
| 7 | Customed, Inc | I | Aug-29-2014 |
| 8 | Ecolab Inc | III | Dec-14-2016 |
| 9 | Ecolab Inc | II | Sep-07-2016 |
| 10 | Ecolab Inc | II | Feb-10-2014 |
| 11 | Halyard Health, Inc | II | Dec-08-2016 |
| 12 | Intuitive Surgical, Inc. | II | Apr-06-2015 |
| 13 | Volcano Corporation | II | Mar-03-2016 |