Product code EYY
- Device name
- Drape, Urological, Disposable
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4370
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00748426262076 | AQUABLATION THERAPY® | Microtek Medical LLC | 2026-04-06 |
| 00850055427099 | Essential Drape 1PK | PROCEPT BioRobotics Corporation | 2025-03-13 |
| 07333387044156 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387044125 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387044095 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387044064 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387044033 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387044002 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387043975 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387043944 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387043913 | GentleCath Hydrophilic Kit | Wellspect AB | 2024-06-01 |
| 07333387043739 | SimPro™ Set | Wellspect AB | 2024-05-02 |
| 07333387043852 | SimPro™ Set | Wellspect AB | 2024-05-02 |
| 07333387043678 | SimPro™ Set | Wellspect AB | 2024-05-02 |
| 07333387043494 | SimPro™ Set | Wellspect AB | 2024-05-01 |
| 07333387043555 | SimPro™ Set | Wellspect AB | 2024-05-01 |
| 07333387043647 | SimPro™ Set | Wellspect AB | 2024-05-01 |
| 07333387043616 | SimPro™ Set | Wellspect AB | 2024-05-01 |
| 07333387043708 | SimPro™ Set | Wellspect AB | 2023-08-28 |
| 07333387043524 | SimPro™ Set | Wellspect AB | 2023-08-28 |
| 07333387043586 | SimPro™ Set | Wellspect AB | 2023-08-28 |
| 07333387043883 | SimPro™ Set | Wellspect AB | 2023-08-28 |
| 07333387043821 | SimPro™ Set | Wellspect AB | 2023-08-28 |
| 07333387043791 | SimPro™ Set | Wellspect AB | 2023-08-28 |
| 07333387043760 | SimPro™ Set | Wellspect AB | 2023-08-28 |
| 00860009122932 | Lithotomy Drape | PROCEPT BioRobotics Corporation | 2023-04-05 |
| 00885380013914 | CONVERTORS | Cardinal Health 200, LLC | 2019-08-01 |
| 10192253017694 | CONVERTORS | Cardinal Health 200, LLC | 2019-07-15 |
| 10885380142970 | CONVERTORS | Cardinal Health 200, LLC | 2017-09-28 |
| 50885380097186 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-21 |