510(k) K192577
- Device
- Actreen Hi-Lite Intermittent Urinary Catheters
- Applicant
- B. Braun Medical Inc.
- 510(k) number
- K192577
- Product code
- GBM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-07
- Date received
- 2019-09-19
- Regulation
- 876.5130
- Classification name
- Catheter, Urethral
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Anita J. Nemeth
- Address
- 901 Marcon Blvd. Allentown PA US 18109 18109
FDA Registration Numbers#
- 3006271008
- 3014404707
- 1423537
- 3007134520
- 1221765
- 3011987967
- 9616668
- 3014656749
- 3010400865
- 8022978
- 9680787
- 1000121056
- 2032112
- 9616088
- 9613662
- 1018233
- 1054241
- 3008729910
- 8043792
- 9710524
- 3010220595
- 2029015
- 1921846
- 3003903031
- 2124215
- 9611590
- 1055236
- 3004111573
- 1825146
- 3008191244
- 3008806809
- 9611712
- 3006606901
- 3030678884
- 3009337401
- 1820334
- 3011020307
- 1061124
- 9612030
- 3009732568
- 3010173425
- 1828132
- 3010288357
- 3015131144
- 3006371704
- 2320762
- 1043214
- 1718873
- 3022518300
- 3005099803
- 1424263
- 3006430057
- 3008102042
- 1000317571
- 1417592
- 3015176887
- 3005941719
- 9610694
- 2320961
- 3006082230
- 3017961114
- 3016761372
- 1480288
- 3008824097
- 9681260
- 8040233
- 3030671614
- 3016863553
- 3006536657
- 3011270181
- 3006405073
- 3016675012
- 3015142802
- 3006017180
- 3007738736
- 1932668
- 3005778470
- 3020976354
- 3008502431
- 3011137372
Source Documents#
Other 510(k) Records For Product Code GBM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Well Lead Medical Co., Ltd. | 2025-03-05 |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Convatec Limited | 2022-06-22 |
| K211436 | Intermittent Catheter (Not Finalized) | Hollister Incorporated | 2022-01-27 |
| K200820 | SpeediCath Compact Set | Coloplast | 2020-11-13 |
| K192904 | SpeediCath Compact Set | Coloplast | 2020-11-02 |
| K200142 | SpeediCath Soft | Coloplast | 2020-07-30 |
| K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | 2020-06-01 |
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | 2020-05-21 |
| K193148 | VaPro Plus Pocket, VaPro Plus | Hollister Incorporated | 2019-12-13 |
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter | Hangzhou Bever Medical Devices Co., Ltd. | 2019-11-27 |
| K191633 | Infyna Chic | Hollister Incorporated | 2019-07-19 |
| K190620 | SpeediCath Flex Coude Pro | Coloplast | 2019-07-10 |
| K183335 | Medline Poly-Cath Red Polymer Urethral Catheter | Medline Industries, Inc. | 2019-06-12 |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | 2019-05-08 |
| K182511 | SimplCath | F&S Medical Solutions, LLC | 2019-03-20 |
Legacy Summary#
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FDA Review#
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