VaPro Pocket
510(k) K143594
VaPro Pocket is a Class II device made by Hollister Incorporated, cleared under FDA 510(k) K143594 on 9 Jan 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143594 | Date9 Jan 2015 | StatusActive |
Official records
- FDA 510(k) database K143594
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GBM
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K143594
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VaPro Pocket 70102-30 | 70102-30 | 00610075052967 | Catheter Gauge 10 Fr; Length 8 in | On the market |
| VaPro Pocket 70122-30 | 70122-30 | 00610075052974 | Length 8 in; Catheter Gauge 12 Fr | On the market |
| VaPro Pocket 70142-30 | 70142-30 | 00610075052981 | Catheter Gauge 14 Fr; Length 8 in | On the market |
| VaPro Pocket 77124 | 77124 | 00610075090778 | Catheter Gauge 12 Fr; Length 16 in | On the market |
| VaPro Pocket 77144 | 77144 | 20610075090789 | Catheter Gauge 14 Fr; Length 16 in | On the market |
| VaPro Pocket 77164 | 77164 | 20610075090796 | Length 16 in; Catheter Gauge 16 Fr | On the market |
Similar devices
Other devices filed under FDA product code GBM (Catheter, Urethral).
- SpeediCath Soft by Coloplast Corp.
- SpeediCath Compact Set by Coloplast Corp.
- SPEEDICATH COMPACT SET (12/18 FR) by Coloplast A/S
- TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG by C. R. Bard, Inc.
- Actreen Mini Intermittent Urinary Catheters by B. Braun Medical, Inc.
- OPEN ENDED URETERAL CATHETER by Van-Tec, Inc.
- ADI CATHETER WITH VALVE by Asia Dynamics, Inc.
- URI-CATH CATHETER by Gesco Intl., Inc.
- ThinkMed Intermittent Catheter with/without Hydrophilic Coating by Thinkmed Medical Technology Co., Ltd.
- O'Neil Intermittent Urinary Catheter 14 Gauge ONSM14 by GO MEDICAL INDUSTRIES PTY. LTD.